Note: Descriptions are shown in the official language in which they were submitted.
CA 2967570 2017-05-17
1
FASTING FORMULATION AND USE THEREOF
FIELD OF THE INVENTION
The present invention relates to a fasting formulation and a method of use
that assists
a patient during a fasting period and to reduce side effects of the fasting.
Furthermore, the invention promotes better recovery from fasting. The
formulation
contains maltodextrin and is devoid of simple sugars. The invention further
relates to
the use of the formulation as a pre-operative for preparing for surgery and
anaesthesia using the formulation.
BACKGROUND OF THE INVENTION
There are many reasons why a person would choose to fast but more than often,
the
reason for fasting is to prepare for surgery and anaesthesia. A period of
fasting may
begin just before midnight for morning surgery and last to the next day even
extending to the afternoon if surgery times are delayed. A fasting period may
last for
as long as 16 to 18 hours.
In this period, the patient will experience considerable changes in metabolism
which
affect the carbohydrate, protein and fat reserves of the body. The
requirements of the
brain for glucose must be satisfied from glycogen stored in the liver. Other
additional
energy sources will come from breakdown of protein in the muscle to amino
acids,
and fat degradation. The breakdown of energy stores can cause physical stress
and
trauma to the body and does not place the patient in the best condition prior
to
surgery. Such fasting regimes may put the body in a dehydrated and catabolic
state
where the body is breaking down protein and fats to provide energy. Headaches,
nausea, lethargy, thirst and hunger are common as a result.
Coordinating a patient fo/.--sKgery is a complex task and the routine
practicalities in
managing this task need to be contemplated. Hospital staff are often tasked
with
providing patients with fasting instructions, usually the day before surgery.
During the
consultation the patients are often presented with a confusing number of
options in
the event that they become hungry or thirsty during the fasting period. Their
options
can include black coffee, no milk in tea, juice but no pulp, food 6 hours
before, clear
fluids two hours before etc. Patients are therefore concerned about ingesting
the right
,
CA 2967570 2017-05-17
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fluids in the event that they may die if they eat or drink anything they
should not or
that their surgery may be cancelled if their allocated anaesthetist finds out
that they
didn't comply. Patients therefore often choose to starve or not drink at all.
As a result
of the avoidance of suitable fluids, the patients become angry, are
dissatisfied with
their treatment in the hospital, disrupt the ward tranquillity and complain
and become
aggressive toward staff when they are hungry and thirsty.
Some patients find the options confusing and theatre times are not always
guaranteed. Patients should only begin fasting from fluids when the patient
has been
allocated a specific theatre time. Too many elderly patients are presenting to
theatre
in a poor metabolic state. Their poor status is often exacerbated because they
find it
difficult to comply with procedures prior to surgery. Providing the patient
with simple
instructions prior to the operation will result in a better outcome.
During the fasting period the body may also experience the reduced
effectiveness of
insulin. A state of insulin resistance is developed. The degree of insulin
resistance
developing after surgery due to this long period of fasting is of major
concern
following surgery. Insulin resistance has been associated with increased
length of
hospital stay.
The stress of surgery additionally results in the release of stress hormones
into the
bloodstream (cortisol from the adrenal glands amongst other hormones). These
hormones result in catabolic derangements of metabolic and physiological
processes.
The catabolism that results causes muscle wasting, impaired immune function
and
wound healing even organ failure and death can result.
It can take approximately three weeks after routine surgery to restore the
normal
balance in metabolism after surgery.
However, administering solutions containing simple sugars such as fructose and
glucose may contribute to insulin resistance. The general practice is to
provide the
patient with carbohydrate solutions including glucose and fructose to assist
in the
recovery from fasting.
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A direct relationship exists between insulin resistance and infectious
morbidity
including surgical site infections (SSI). However, the addition of sugars such
as
fructose and glucose may exacerbate the problem. Furthermore the addition of
fructose is known to cause the unpleasant abdominal side effects of bloating,
cramping and diarrhoea.
Therefore a clear option to the patients in the fasting period would enable
them to
overcome these feelings of hunger and thirst and put the body in a better
condition to
commence healing and recovery and mitigate the stress response associated with
surgery.
It is therefore desirable to provide a simple formulation to be introduced in
a fasting
period such as in a pre-operative stage to prevent starvation, allow metabolic
optimisation of patients and facilitate providing a simple guideline prior to
surgery
which will place the patient at ease at least in regard to the stages prior to
surgery
and anaesthesia and to improve recovery after surgery.
SUMMARY OF THE INVENTION
Fasting prior to surgery will often induce hunger, thirst, headaches, nausea
and
lethargy and patients having to fast will be irritable as a consequence of
extended
fasting.
Accordingly, in one aspect there is provided a formulation when used to reduce
side
effects of fasting comprising maltodextrin and is devoid of simple sugars. The
formulation of the present invention is a simple solution that contains
maltodextrin in
the absence of other simple sugars such as but not limited to glucose,
fructose and
galactose.
In another aspect there is provided a use of maltodextrin in the absence of
simple
sugars in the preparation of a formulation which is devoid of simple sugars to
reduce
side effects of fasting.
In yet another aspect of the invention there is provided a method for
preparing for
surgery, said method comprising:
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ceasing eating for a time prior to surgery to induce fasting;
ingesting a formulation comprising maltodextrin and devoid of simple sugars
during the fasting at about at least 90 minutes prior to surgery.
The invention also provides instructions for ingesting the formulation to
alleviate the
side effects of fasting and prepare the body for pre- and post-surgery.
Patients who
prepare the body with the formulation are less likely to experience post-
surgery
complications and recover more easily than those that do not.
Other aspects of the present invention will become apparent to those
ordinarily skilled
in the art upon review of the following description of specific embodiments of
the
invention.
Where the terms "comprise", "comprises", "comprised" or "comprising" are used
in this
specification (including the claims) they are to be interpreted as specifying
the
presence of the stated features, integers, steps or components, but not
precluding the
presence of one or more other features, integers, steps or components, or
group
thereof.
DESCRIPTION OF THE FIGURES
Figure 1 shows fasting cards that can be provided to patients for the use of
the
formulation prior to surgery. (A) Bowel prep fasting card; (B) Morning surgery
fasting
card; (C) Afternoon surgery fasting card; (D) Morning surgery fasting card for
one
bottle and (E) Afternoon surgery fasting card for one bottle.
DETAILED DESCRIPTION OF THE INVENTION
Patients that are required to fast prior to surgery will often experience
hunger, thirst,
headaches, nausea and lethargy and will be irritable as a consequence of
extended
fasting. Such fasting regimes may put the body in a dehydrated and catabolic
state,
where the body is breaking down protein to provide energy. However, the
options
available to the patient during this period to satisfy these feelings of
hunger and thirst
and subdue other side effects are not always clear. Hence, the patient will
often do
nothing or simply drink water which does not satisfy the feelings of hunger or
provide
sufficient energy sources.
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Accordingly in an aspect of the present invention there is provided a
formulation when
used to reduce side effects of fasting comprising maltodextrin and is devoid
of simple
sugars.
5
The formulation of the present invention is a simple solution that contains
maltodextrin
in the absence of other simple sugars such as but not limited to glucose,
fructose and
galactose. Because there are no simple sugars present, the formulation
presents
less gastrointestinal discomfort and upset whilst providing fluids and energy
in the
form of maltodextrin. This carbohydrate drink as a liquid meal introduced at
the
preoperative stage can prevent starvation and allows metabolic optimisation of
patients.
The present invention is a form of prophylactic treatment, which can minimise
insulin
resistance that results after surgery. The complex carbohydrate drink is
devoid of
fructose and other simple sugars but comprises maltodextrin. Maltodextrin has
a high
glycaemic index which is higher than fructose causing an insulin response in
the
human body higher per gram of maltodextrin compared with fructose. Therefore
without being limited by theory, it is postulated that the formulation of the
present
invention which contains maltodextrin with no simple sugars such as fructose
will
generate a more exaggerated insulin response from the pancreas. The higher
insulin
response puts the body into an anabolic mode which is desired post-surgery to
help
heal wounds. The formulation specifically excludes simple sugars in order to
stimulate a higher insulin response. Insulin is the main anabolic hormone of
the body
and counteracts the stress hormone response that occurs with surgery.
Fasting is a willing abstinence or reduction from some or all food, drink, or
both, for a
period of time. In a physiological context, fasting may refer to the metabolic
status of
a person who has not eaten overnight, or to the metabolic state achieved after
complete digestion and absorption of a meal. There are many reasons for
fasting.
However, for the purposes of the present invention, the fasting is induced
preferably
before surgery and anaesthesia and the formulation of the present invention is
preferably intended for use as a pre-operative drink. Many people may also
fast as
part of a medical procedure or check-up such as a colonoscopy.
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The absence of simple sugars such as glucose, fructose, maltose and galactose
prevents osmolality rising and for fructose can cause symptoms of abdominal
cramps,
bloating and diarrhoea. This is often encountered in sports drinks and juices
which
are often too sweet. Gastric emptying is faster with lower osmolality drinks
and rapid
gastric emptying is important for achieving an empty stomach prior to
anaesthesia.
Simple sugars are carbohydrates that are quickly absorbed by the body to
produce
energy. They are also classified as "simple" because they contain only one or
two
units of sugar or saccharides.
The formulation of the present invention is absent or devoid of simple sugars
such as
glucose and fructose, more preferably fructose.
Fructose has been implicated in a number of disorders including weight gain,
insulin
resistance, reduced insulin sensitivity and many other carbohydrate metabolism
disorders including fructose metabolism disorders, galactosemia, glycogen
storage
diseases and pyruvate metabolism disorders. Additionally, patients ingesting
fructose
can experience gastrointestinal discomfort.
Preferably, the formulation is free of fat, glucose, lactose, protein and
fibre.
The use of the term "absent" or "devoid" with respect to the simple sugars in
the
formulation means that the simple sugars are not present in an amount which
would
provide any measurable or effective levels of calories which would impart an
effect on
the body as a result of the contributions made by the presence of the simple
sugars
such as glucose and fructose.
The formulation is preferably a clear fluid designed to empty rapidly from the
stomach.
However, the formulation may be a concentrate that can be dilute to form a
beverage.
The formulation is preferably in the form of a liquid and may be further
formulated into
a beverage. It may be provided as a syrup which can be diluted to taste.
Generally,
the dilution will be with water. Alternatively, the formulation may be
provided as a gel
that can be dissolved in the mouth, preferably with water.
However, it is
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contemplated that a concentrated form of the formulation may be provided which
can
be diluted.
Preferably the formulation is more alkaline than sports drinks and it is
preferred that
the formulation have a pH of greater than 4Ø Preferably, the pH is in the
range of
4.0 to 5Ø More preferably the pH is 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7,
4.8, 4.9 or
5Ø Most preferably, the pH is 4.2. Increasing pH results in less damage in
the event
of aspiration during surgery. Acidity regulators such as sodium citrate and
potassium
citrate may be used to regulate the pH and minimise gastric acidity.
Any food grade acids known and available to the skilled addressee may be used
to
adjust the pH of the formulation. Acids such as citric acid, sodium citrate or
potassium citrate, or acetic acid may be used.
The only carbohydrate in the formulation is maltodextrin. There may be other
additives such as flavourings and colourings, however any carbohydrates
associated
with these is minimal to the point of having no effect on the body. Simple
sugars such
as glucose, fructose or galactose, preferably fructose are absent from the
formulation.
Maltodextrin is a complex carbohydrate and may be derived from any starch such
as
corn or wheat. Maltodextrin is generally available and commonly used as a food
additive. However, in these uses, it is often accompanied with other sugars
such as
glucose and fructose since maltodextrin is moderately sweet or almost
flavourless on
its own. Hence when used in a pre or postoperative formulation manufacturers
will
accompany the maltodextrin with other sweeteners.
Previously, maltodextrin has not been used on its own in a pre or
postoperative
formulation. As stated above, it has little or no flavour and prior
formulations
containing maltodextrin will have other sweeteners such as fructose and
glucose to
improve palatability. The formulation is designed to alleviate hunger
associated with
prolonged fasting and hence the formulation is preferably designed to deliver
at least
about 100 calories per serving. These calories may be ingested as one serving
or
multiple servings prior to surgery. Preferably, all of the calories are
derived from
maltodextrin in the formulation.
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The calories may be derived from at least 50 grams of maltodextrin.
Maltodextrin may be in the form of Maltodextrin with a Dextrose Equivalent
value of
15 to 19.
In a preferred formulation, there may be at least 10 percent maltodextrin up
to 100
percent maltodextrin in the formulation. Preferably there is provided a
formulation with
percent, 20 percent, 30 percent, 40 percent, 50 percent, 60 percent, 70
percent,
10 80 percent, 90 percent or 100 percent maltodextrin. More preferably, the
maltodextrin
component is 10 percent, 11 percent, 12 percent, 13 percent, 14 percent, 15
percent,
16 percent, 17 percent, 18 percent, 19 percent or 20 percent, most preferably
14
percent maltodextrin. The remaining part of the formula will comprise water,
acids,
acidity regulators, natural flavours and colours.
The osmolality of the formulation is best kept lower than physiological range.
Preferably, the formulation is about 130 to 180 mOsm/kg, preferably the
osmolality is
in the range of 140 to 180 mOsm/kg. In one embodiment the osmolality is 170,
171,
172, 173, 174 or 175 mOsm/kg. More preferably, the osmolality is 174 mOsm/kg.
In
another embodiment, the osmolality is 148, 149, 150, 151, or 152 mOsm/kg. More
preferably, the osmolality is 149 mOsm/kg. More preferably, the osmolality of
the
formulation is provided by the maltodextrin alone and not from other sugars
such as
simple sugars which will be absent from the formulation of the present
invention.
Other flavourings may be used providing they do not substantially alter or
contribute
to the calorie content or the osmolality provided by the maltodextrin alone.
Natural
flavourings may be used such as but not limited to natural mango, coconut,
lime,
ginger, peppermint, coffee, tea, raspberry, lemon or orange.
Side effects of fasting can include hunger, thirst, headaches, nausea and
lethargy as
well as gastrointestinal discomfort.
Patients breaking a fasting period with a
carbohydrate drink often experience gastrointestinal discomfort from the
ingestion of
the carbohydrate drinks that are sometimes offered as pre or postoperative
drinks.
These contain sugars such as glucose and fructose often added to improve
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palatability or caloric value. However the present invention is absent these
simple
sugars such as glucose and fructose and preferably, the formulation of the
present
invention reduces the side effects of gastrointestinal discomfort.
GI discomfort may come in the form of cramps, abdominal bloating, nausea and
diarrhoea.
When used during fasting the formulation can keep the body nourished, hydrated
and
comfortable before surgery with reduced GI discomfort. This alleviates the
hunger and
thirst that accompanies fasting and prevents other side effects such as
headaches,
light headedness, nausea and lethargy so often experienced during fasting. In
the
preoperative phase, the patients are in a better physical and mental state.
Continued use of the formulation after fasting and/or surgery enhances
recovery and
helps reduce post-surgical complications such as infection by inducing immune
function and reducing insulin resistance and insensitivity. During the
postoperative
phase and with the use of the formula, the immune response is facilitated by
minimising postoperative hyperglycaemia when excess blood sugar can inhibit
phagocytosis and chemotaxis.
In another aspect of the present invention, there is provided a use of
maltodextrin in
the absence of simple sugars in the preparation of a formulation which is
devoid of
simple sugars to reduce side effects of fasting.
Maltodextrin has been used in sports drinks and pre-operative drinks. However,
it
has not been used alone in the absence of simple sugars to provide a
formulation that
reduces side effects of fasting such as hunger and thirst, preferably with
reduced GI
discomfort.
Applicants have found that sports drinks and pre-operative drinks can cause GI
discomfort especially if consumed during and after fasting. Often they will
contain
simple sugars such as fructose.
Preferably the formulation, in which the maltodextrin is used, is described
herein.
CA 2967570 2017-05-17
In yet another aspect of the present invention there is provided a method for
preparing a patient for surgery and anaesthesia, said method comprising the
patient:
5
ceasing eating for a time prior to surgery and anaesthesia to induce fasting
in
the patient;
ingesting a formulation comprising maltodextrin and which is devoid of simple
sugars during the fasting at about at least 90 minutes prior to surgery and
anaesthesia.
The formulation of the present invention is provided as a fasting formulation
which
can reduce side effects of fasting. It is contemplated that an ideal use is
that of a
preoperative formulation designed to prepare a patient for surgery and
anaesthesia.
Prior to surgery and anaesthesia, patients are asked to fast. Preferably this
time will
be from at least 12 hours prior to surgery and anaesthesia. However shorter
times
may be adopted providing the stomach is suitably emptied.
Patients are called or seen in preadmission clinic before surgery and
anaesthesia.
The patients are presented with a confusing array of multiple fasting options
to assist
them through the fasting period including black coffee, no milk in tea, apple
juice, no
pulp, food 6 hours before, clear fluids two hours before etc., whereby the
patient
comprehends that basically they might die if they eat or drink anything, and
that their
surgery will be cancelled if their allocated surgeon or anaesthetist finds out
they didn't
comply.
Complete oral abstinence is presented as being equivalent, if not more
superior to
having a liquid meal. As a result of this, patients starve themselves in an
attempt to be
"more safe". This practice harms the patient and leaves them in a less
prepared state
for surgery and jeopardises their recovery following surgery.
Preferably prior to surgery and anaesthesia, a serving of the formulation of
the
present invention is ingested by the patient. Ideally, the formulation is
ingested at
least 90 minutes before surgery and anaesthesia. Preferably the ingestion is
about
120 minutes before surgery and anaesthesia. This time will be sufficient for
the
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formulation to reduce the side effects of fasting such as hunger and thirst
and avoid
the irritability prior to surgery and anaesthesia that results from other side
effects such
as headaches and light headedness.
A serving of the formulation may include at least 25 grams of maltodextrin.
Preferably, a serving may include maltodextrin in the range of 25 to 75 grams;
more
preferably a serving may include any of 25, 30, 35, 40, 45, 50, 55, 60, 65, 70
or 75
grams of maltodextrin. More preferably, a serving may include 50 grams of
maltodextrin. One or two servings of the formula may be consumed depending on
the
patient's level of hunger and/or thirst. However, 25 to 75g of maltodextrin
should be
consumed; preferably 50 grams may be served prior to surgery and anaesthesia.
This amount of maltodextrin may be beneficial for reducing insulin resistance
post-
operatively.
The exclusion of fructose from the preoperative carbohydrate drink is to
minimise
post-operative insulin resistance. Fructose may contribute to insulin
resistance so
that avoiding fructose may make the formulation of the present invention more
effective at preventing insulin resistance than other surgery specific
preoperative
carbohydrate drinks.
Preferably a first ingestion of the formulation is about at least 4 hours
before surgery
and a second ingestion of the formulation is about at least 90 minutes prior
to surgery.
More preferably the formulation is ingested at a time prior to administration
of
anaesthesia so that the stomach is close to empty when anaesthesia commences.
Preferably patients who are awaiting surgery or surgical review may be offered
approximately 200mIs of the formulation every hour. This may be sufficient to
alleviate feelings of hunger and thirst whilst optimally preparing the patient
for surgery
and anaesthesia.
In another embodiment the method includes instructions for preparing for
surgery.
The instructions may be provided on a fasting card to the patient during
fasting. The
fasting card may provide dosing and schedule times for ingestion of the
formulation
prior to surgery. This will alleviate confusion as to the types of fluids that
can be
CA 2967570 2017-05-17
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ingested and the timing for the ingestion that will best prepare the patient
for pre- or
post-surgery. If the patient is better prepared pre- or post-surgery it is
more likely that
the patient will perform better pre- or post-surgery and recovery times will
be
shortened.
In another aspect there is provided a fasting card when used by a patient
during
fasting or prior to surgery said fasting card providing dosing and schedule
times for
ingestion of a formulation comprising maltodextrin and which is devoid of
simple
sugars.
In one embodiment the fasting card refers to a formulation according to the
present
invention.
The present invention will now be more fully described by reference to the
following
non-limiting Examples.
EXAMPLES
Example 1: Fasting formulation
A formulation comprising maltodextrin for use as a pre-operative formulation
was
prepared so that 50g maltodextrin was administered in one serving to a patient
prior
to surgery. The following formulation was prepared:
Maltodextrin (14%) 14g
Water Approx. 100mIs
Other ingredients including acid (330), 20mg
acidity regulators* - Sodium citrate and
potassium citrate (331, 332), natural
flavours (mango, coconut), natural
colours (beta-carotene, anthocyanins)
The formula has the following characteristics:
pH Osmolarity Energy (kj) Sodium Complex Simple
(mOsm) per per 100 (mg) per carbohydrate sugars
kg mls 100 mls
4.1 174mOsm/kg 250 20 100% 0%
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Example 2: Reduction of gastrointestinal discomfort
Patients were tested for their gastrointestinal response to various pre-
operative drinks
compared to the formulation of the present invention.
A formulation was prepared in accordance with Example 1 (Dex TM) and compared
against other available pre-operative formulations Preop TM and ClearFastTM.
PreopTM is a 0.5kcal/ml, clear, non-carbonated, lemon flavoured, iso-osmolar
carbohydrate drink. It contains water, maltodextrin, fructose, tri potassium
citrate, tri
sodium citrate, acidity regulator (citric acid), flavour (lemon), sweetener
(acesulfame
K), sweetener (sodium saccharine).
ClearFastTmis a clear, carbohydrate rich drink, made for patients fasting
before
surgery or procedures. It contains filtered water, maltodextrin, crystalline
fructose, L-
Citrulline, Natural Flavours, Sodium citrate, Citric acid, Malic acid, Stevia
Rebaudiana,
Monopotassium Phosphate, Zinc Sulphate, Vitamin A Palmitate, Sodium Selenite
complex carbohydrates, electrolytes, Vitamin A, Selenium, Zinc, and L-
citrulline.
50 patients fasted for 6 hours and then consumed 600mIs of DexTM over a 2
minute
period. 2 patients complained of stomach cramps.
50 patients fasted for 6 hours and then consumed 600mIs of a competitor drink
(PreopTTM (25 patients), ClearFastTM (25 patients)) that contained 6g
Fructose. The
drink was consumed over 2 mins.
In the PreopTTM group 4 patients complained of GI upset, and in the
ClearFastTM group
5 patients complained of GI upset.
In total 9 patients complained of GI upset when drinking a known pro-operative
drink
containing fructose compared to Dex TM .
Example 3: Use of formulation Dex TM prior to surgery
The pre-operative formulation is ingested prior to surgery. However, a
preferred
regime of fasting is adhered to ensuring that the body is ready for surgery.
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14
(a) For morning surgery
Patients are requested to stop eating at midnight and before retiring for the
evening
before surgery to induce fasting. Once awake, preferably in the morning they
are
encouraged to consume one serving of the formulation prepared in accordance
with
Example 1.
The patient is then encouraged to consume a second serving of the formulation
from
Example 1 at approximately 90 mins and up to 2 hrs before admission time.
Alternatively, both servings may be consumed at this time.
The patient is also encouraged to consume the formulation on an as needs basis
prior
to surgery.
(b) For Afternoon surgery
Patients are requested to stop eating at about 7.00am to induce fasting prior
to the
afternoon surgery. At approximately 11.00am they are encouraged to consume one
serving of the formulation prepared in accordance with Example 1.
The patient is then encouraged to consume a second serving of the formulation
from
Example 1 at approximately 90 mins and up to 2 hrs before admission time.
Alternatively, both servings may be consumed at this time.
Best results are obtained when at least two servings of the the formulation
are
consumed before surgery.
The patient is also encouraged to consume the formulation on an as needs basis
prior
to surgery.
For paediatric patients, the same regime may be applied except that the first
serving
is replaced with 10m1/kg (up to a maximum of 200mIs) and the second serving is
replaced with 10m1/kg (up to a maximum of 200mIs).
CA 2967570 2017-05-17
Simple instructions for the use of the formulation may be provided on Fasting
Cards
that are easily provided to the patients with simple instructions for the use
of the
formulation prior to surgery (see Figure 1). The Fasting Cards when used along
with
the formulation alleviates confusion for the types of fluids that a patient
can ingest
5 prior to surgery and also provides an indication of the schedule for
ingestion to best
prepare the patient pre- and post-surgery.
While the foregoing written description of the invention enables one of
ordinary skill to
make and use what is considered presently to be the best mode thereof, those
of
10 ordinary skill will understand and appreciate the existence of
variations, combinations,
and equivalents of the specific embodiment, method, and examples herein. The
invention should therefore not be limited by the above described embodiment,
method, and examples, but by all embodiments and methods within the scope and
spirit of the invention as broadly described herein.
