Randomized clinical trial

Randomized clinical trial of the effects of oral preoperative

carbohydrates on postoperative nausea and vomiting after
laparoscopic cholecystectomy
J. Hausel1 , J. Nygren1 , A. Thorell1 , M. Lagerkranser2 and O. Ljungqvist1
1
Centre of Gastrointestinal Disease, Ersta Hospital and Karolinska Institutet and Centre for Surgical Sciences, Karolinska University Hospital
Huddinge, and 2 Department of Anaesthesiology and Intensive Care, Karolinska University Hospital Solna, Stockholm, Sweden
Correspondence to: Dr J. Hausel, Centre of Gastrointestinal Disease, Ersta Hospital, PO Box 4622, SE 116 91 Stockholm, Sweden
(e-mail: jonatan.hausel@ersta.se)

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Background: A carbohydrate-rich drink (CHO) has been shown to reduce preoperative discomfort. It
was hypothesized that it may also reduce postoperative nausea and vomiting (PONV).
Methods: Patients undergoing elective laparoscopic cholecystectomy under inhalational anaesthesia (127
women and 45 men; mean(s.d.) 48(15) years) were randomized to either preoperative fasting, intake of
CHO (50 kcal/100 ml, 290 mOsm/kg) or placebo. The non-fasting groups were double-blinded; patients
ingested 800 ml of liquid on the evening before surgery and 400 ml 2 h before anaesthesia. Nausea and
pain scores on a visual analogue scale (VAS) and episodes of PONV were recorded up to 24 h after
surgery.
Results: The incidence of PONV was lower in the CHO than in the fasted group between 12 and
24 h after surgery (P = 0·039). Nausea scores in the fasted and placebo groups were higher after
operation than before admission to hospital (P = 0·018 and P < 0·001 respectively), whereas there was
no significant change in the CHO group. No intergroup differences in VAS scores were seen. The use
of anaesthetics, opioids, antiemetics and intravenous fluids was similar in all groups.
Conclusion: CHO may have a beneficial effect on PONV 12–24 h after laparoscopic cholecystectomy.

Presented in part to the 25th Congress of the European Society for Clinical Metabolism and Nutrition, Cannes, France,
September 2003, and published in abstract form as Clin Nutr 2003; 22(Suppl 1): S76
Paper accepted 3 November 2004
Published online 28 February 2005 in Wiley InterScience (www.bjs.co.uk). DOI: 10.1002/bjs.4901

Introduction Preoperative carbohydrate loading has been shown to

Despite the development of strategies to prevent and treat
postoperative nausea and vomiting (PONV)1 – 5 , it still
occurs in 20–30 per cent of adult patients1,2,5,6 . An even
higher incidence has been reported in women, those with
a history of motion sickness or previous PONV, non-
smokers and with use of opioids1,6,7 . The choice of anaes-
thetic as well as the duration and type of surgery may also
affect its incidence1,7 . From the patient’s perspective, nau-
sea and vomiting may be an even worse experience than pain
after surgery8 . PONV may also delay hospital discharge or
necessitate overnight admission after day-case surgery1,2,9 ,
with associated economic consequences. Recently, a mul-
timodal approach, combining several potentially beneficial
factors to minimize PONV, has been discussed1,10 .
reduce postoperative catabolism and insulin resistance11,12 .
To facilitate this treatment, a specially designed
carbohydrate-rich drink (CHO) has been developed13 .
CHO neither delays gastric emptying13,14 nor affects gas-
tric acidity14 and is therefore considered safe to use in
elective surgical patients without risk factors for pulmonary
aspiration15 . In addition to its metabolic effects, CHO has
been shown to improve preoperative wellbeing in patients
scheduled for elective abdominal surgery14 . Specifically,
patients who received CHO were found to be less hungry
and less anxious than those receiving placebo (flavoured
water) or those fasting overnight14 . Furthermore, a sig-
nificant increase in preoperative nausea was found in the
placebo group, but not in the CHO or fasting groups14 .
Similarly, in a trial16 comparing CHO with placebo given

Copyright  2005 British Journal of Surgery Society Ltd British Journal of Surgery 2005; 92: 415–421
Published by John Wiley & Sons Ltd
416
before laparoscopic cholecystectomy, preoperative nausea
and discomfort were less common in the CHO group, but
there was no effect on postoperative wellbeing, including
nausea and vomiting16 .
The aim of the present study was to further
investigate the possible effects of CHO on PONV after
laparoscopic cholecystectomy in a randomized clinical
trial. This standard surgical procedure is commonly
performed either in a day-case setting or with a 1-night
hospital stay. Incidences of PONV of to 38–60 per cent
have been reported within 24 h after laparoscopic
cholecystectomy16,17 and such symptoms may delay
discharge from hospital9 .
Patients and methods
Adult patients scheduled for elective laparoscopic cholecys-
tectomy, and who were eligible for intake of preoperative
clear fluids according to the guidelines of the Swedish Soci-
ety of Anaesthesia and Intensive Care18 , were considered
for inclusion. Patients with conditions (including phar-
macological treatments) that might impair gastrointestinal
motility, gastro-oesophageal reflux and those who had the
potential for difficult airway management were therefore
excluded. Additional exclusion criteria were diabetes mel-
litus, American Society of Anesthesiologists physical status
grade III or higher and pregnancy. Patients with suspected
(jaundice or based on laboratory findings) or documented
choledocholithiasis were not included, to allow standard-
ization of the surgical trauma. To achieve standardization
of the duration of fasting before surgery in each group,
patients whose operation was scheduled to start after noon
were not included.
Three hospitals in the Stockholm area (Karolinska,
St Göran and Ersta Hospital) took part in the study.
During the study period (20 months) 174 patients were
enrolled, representing approximately 22 per cent of all
patients undergoing laparoscopic cholecystectomy in these
hospitals. Two patients chose to discontinue the study
after surgery, leaving 172 patients for analysis. There was
no selection or stratification of patients with regard to the
presence of risk factors for PONV. The procedures and
purposes of the study were fully explained to, and agreed
by, each patient before entering the study. Approval for
the investigation was obtained from the Research Ethics
Committee at Karolinska Institutet.
The patients were assigned, according to a computer-
generated randomization list, to one of three preoperative
treatment groups: fasting from midnight, preparation with
a placebo drink or preparation with CHO. The patients,
investigators and nursing staff were all blinded to the
Copyright  2005 British Journal of Surgery Society Ltd
Published by John Wiley & Sons Ltd
J. Hausel, J. Nygren, A. Thorell, M. Lagerkranser and O. Ljungqvist
CHO and placebo treatments, whereas fasting patients
were unblinded. CHO and placebo drinks have previously
been shown to be indistinguishable in taste14 , and the
products were provided in identical packaging.
During the evening before surgery, patients in the
CHO group ingested 800 ml of a clear carbohydrate-rich
drink (12·5 per cent carbohydrates, 50 kcal/100ml, 290
mOsm/kg, pH 5·0, Nutricia preOp ; Nutricia, Zoeter-
meer, The Netherlands)13 . The placebo group consumed
the same quantity of flavoured water (0 kcal/100 ml,
pH 5·0).
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All patients were allowed to eat and drink freely
before midnight. After midnight, nothing was allowed by
mouth, except for a single morning dose of 400 ml of the
appropriate drink in the CHO and placebo groups. The
morning drink was taken at least 2 h before premedication
because of the risk of opioid-induced slowing of gastric
emptying.
Surgery and anaesthesia
All patients were scheduled for laparoscopic cholecystec-
tomy, and the planned length of hospital stay was 24 h. A
standard four-port technique with carbon dioxide insuffla-
tion of the peritoneal cavity was used, with an insufflation
pressure below 12 mm Hg.
For premedication, ketobemidone 2·5–7·5 mg was given
intramuscularly at least 2 h after the morning drink in
the CHO and placebo groups and at the corresponding
time in the fasted group. General anaesthesia was
induced intravenously with thiopental 5 mg/kg and was
maintained with isoflurane. Fentanyl 0·1 mg was given
before induction and as needed during surgery (0·05–0·1-
mg boluses). Atracurium 0·5 mg/kg was given to facilitate
endotracheal intubation. A combination of neostigmine
and glycopyrrolate (2·5 and 0·5 mg respectively) was
given when reversal of muscle relaxation was required.
Nitrous oxide (70 per cent in oxygen) was included in the
anaesthetic protocol, but could be omitted at the discretion
of the anaesthetist or surgeon. In patients with a previous
history of PONV, motion sickness or another apparent risk
factor for PONV, prophylaxis with intravenous droperidol
(1·25 mg) was given at the end of anaesthesia.
Infusion of intravenous fluids was started at the induction
of anaesthesia, and continued until the morning of the day
of discharge. Non- or low-caloric balanced infusions with
a maximum glucose concentration of 25 mg/ml were used.
For postoperative pain relief, acetaminophen 1 g
was given rectally during surgery in all patients and
continued orally after operation (1g every 6 h). If
insufficient, this was combined with the oral opioids
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Nausea and vomiting after laparoscopic cholecystectomy 417

codeine (60 mg every 6 h) or dextropropoxyphene (50 mg
every 8 h) according to local clinical routines. For
treatment of postoperative breakthrough pain intravenous
or imtramuscular ketobemidone (2·5–5-mg boluses)
was used. Rescue medication for PONV was given
intravenously at the request of the patient, and after clinical
assessment by the attending anaesthetist or surgeon;
droperidol 0·5 mg, dixyrazine 10–20 mg or ondansetron
4–8 mg was used.
Assessment of nausea and vomiting, and pain
and delimited at both ends by vertical lines labelled as
the extremes of the measured variable (no nausea/pain =
0 mm, worst imaginable nausea/pain = 100 mm).
Statistical analysis
There is no specific procedure by which a power calculation
can be performed on outcome measures of ordinal data22 ,
such as VAS values. When planning the study, no data were
available on the effects of CHO on PONV. Therefore,
the sample size was extrapolated from a previous study

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Two methods were used to assess PONV. The nursing staff
objectively recorded episodes of PONV, defined as either
spontaneous complaints of nausea or retching or vomiting7.
Retching was defined as vomiting without production of
liquid19 . Predefined registration periods were 0–4, 4–12
and 12–24 h after surgery.
In addition, the patients rated their sense of nausea
using a 100-mm visual analogue scale (VAS)7,14,19,20 , at the
preadmission visit 1 week before surgery and on the day
after surgery, that is at about 24 h after operation which
was the planned time of hospital discharge. VAS scores
for overall pain were obtained in parallel17,21 . Patients
were instructed to rate the nausea and pain present at the
time of assessment. The VAS was horizontal, ungraded
of the effects of CHO on preoperative VAS scores for
wellbeing14 . A sample size of 50–60 in each of the
three study groups had yielded significant differences in
the previous study, and this group size was assumed
to be sufficient to detect differences in postoperative
measurements.
All analyses were performed and presented on the basis of
intention to treat. Patients who eventually required an open
surgical procedure were therefore included in the analysis.
Exclusion of these patients did not significantly affect the
variables studied. The Kruskal–Wallis test was used for
intergroup testing of VAS data, whereas Wilcoxon’s test
was used for intragroup testing. Correlations of VAS data
were analysed with the Spearman rank test. Binominal
data were analysed with the χ2 test and other intergroup

Table 1 Demographic and surgical data, and details of anaesthetics, pharmacological treatments and infusions

Fasted (n = 58) Placebo (n = 59) CHO (n = 55) P

Sex ratio (F : M) 45 : 13 41 : 18 41 : 14 0·603§

Age (years)* 48·0(14·9) 46·8(14·9) 48·3(14·6) 0·855¶
Body mass index (kg/m2 )* 25·2(2·8) 23·8(2·9) 24·2(3·0) 0·074¶
Ketobemidone in premedication 58(100) 59(100) 55(100)
Dose (mg)* 5·2(1·5) 5·1(2·1) 5·0(1·2) 0·837¶
Intraoperative fentanyl 58(100) 59(100) 55(100)
Dose (mg)* 0·2(0·1) 0·2(0·1) 0·2(0·1) 0·414¶
Intraoperative nitrous oxide 27(46) 28(47) 23(43) 0·812§
Intraoperative neostigmine and glycopyrrolate 45(78) 44(75) 39(71) 0·718§
Intraoperative droperidol† 18(31) 19(32) 20(37) 0·820§
Postoperative droperidol, dixyrazine or ondansetron‡ 23(41) 19(33) 18(33) 0·644§
Postoperative ketobemidone 43(74) 40(67) 32(57) 0·194§
Dose (mg)* 9·4(6·6) 7·8(4·7) 7·2(6·7) 0·462¶
Intraoperative and postoperative infusions 58(100) 59(100) 55(100)
Infused volume (ml)* 2450(552) 2314(538) 2447(521) 0·369¶
Infused energy (kcal)* 164(105) 143(91) 152(77) 0·541¶
Duration of operation (min)* 75(41) 67(33) 69(36) 0·535¶
Intraoperative blood loss (ml)* 9(36) 5(17) 18(74) 0·308¶
Duration of hospital stay (days)* 1·3(0·9) 1·2(0·6) 1·2(0·7) 0·918¶
No. of patients not discharged 24 h after surgery 8 9 7 0·926§
Required an open procedure 2 1 2
PONV 2 1 0
Other (pain, psychosocial reasons) 4 7 5

Values in parentheses are percentages unless indicated otherwise; *values are mean(s.d.). †Prophylaxis against postoperative nausea and vomiting
(PONV); ‡treatment of PONV. CHO, carbohydrate-rich drink. §χ2 test; ¶ANOVA and t test.

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Published by John Wiley & Sons Ltd
418 J. Hausel, J. Nygren, A. Thorell, M. Lagerkranser and O. Ljungqvist

differences were investigated using ANOVA and t test.
In addition, for analysis of the occurrence of PONV
exact binary logistic regression was used. P < 0·050 was
considered statistically significant.
Results
Demographic and surgical data, as well as the use of
anaesthetics, intravenous infusions and drugs with a
potential effect on PONV, are summarized in Table 1.
There were no significant intergroup differences in these
15 (27 per cent) in the CHO group had one or more
episodes of nausea or vomiting (P = 0·305) (Table 2). The
incidence of PONV decreased significantly over time in
the CHO (P < 0·001) and placebo (P = 0·006) groups,
but not in the fasted group (P = 0·067). The incidence
of PONV was similar in the three groups during the first
12 h. However, between 12 and 24 h after cholecystectomy
significantly more patients in the fasted group than in
the CHO group experienced nausea and vomiting (odds
ratio (OR) 8·33 (95 per cent confidence interval (c.i.)
1·08 to 333·33); P = 0·039). There was no corresponding

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variables. There were no complications associated with
the intake of CHO or placebo, and there were no major
surgical complications.
During the 24 h after surgery, 23 (40 per cent) of the
fasted patients, 23 (39 per cent) in the placebo group and
difference between the placebo and CHO groups (OR 3·89
(95 per cent c.i. 0·37 to 120·00); P = 0·401) or between
the fasted and placebo groups (OR 2·19 (95 per cent c.i.
0·55 to 10·54); P = 0·345). Analysis of the subgroup of
women (data not shown) revealed a similar pattern. None

100 ∗

80
Fasted
Placebo
60
VAS (mm)

CHO

40

20

0
Before admission Pain 24 h postop.
a Nausea
∗ ∗
100 ∗

80
Fasted
Placebo
60
VAS (mm)

CHO

40

20

0
Before admission Pain 24 h postop.
b Pain

Fig. 1a Nausea and b pain scores measured on a visual analogue scale (VAS) before admission to hospital and 24 h after laparoscopic
cholecystectomy in patients who fasted overnight (n = 58), those prepared with a clear non-caloric placebo drink (n = 59) and those
prepared with a clear 12·5 per cent carbohydrate drink (CHO) (n = 55). Boxes represent 25th, 50th and 75th percentiles, and whiskers
the 10–90th percentiles. Individual points are within 0–10th and 90–100th percentiles. * P < 0·001, † P = 0·018 versus before admission
(Wilcoxon’s test)

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Nausea and vomiting after laparoscopic cholecystectomy 419

Table 2 Number of patients with nausea and vomiting after The patients were unselected with regard to the presence
elective laparoscopic cholecystectomy of risk factors for PONV1,6,7 , and the sex ratio was similar
in the three groups. The perioperative care and anaesthetic
Fasted Placebo CHO
Time after surgery (n = 58) (n = 59) (n = 55) P technique in the study were in accordance with local clinical
practice, and all patients received volatile anaesthetics and
0–4 h
≥ 1 episodes of PONV 16 15 14 0·955*
long-acting opioids. These drugs may have increased the
Vomiting 2 1 3 risk of PONV1,6,7 , but the pharmacological treatment,
4–12 h including use of prophylactic antiemetics, did not differ
≥ 1 episodes of PONV 5 8 5 0·630*
between study groups. The baseline risk for PONV was
Vomiting 0 3 0
12–24 h therefore assumed to be equal in the three groups.
≥ 1 episodes of PONV 8 4 1 0·039† A VAS has been used previously for the assessment of

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Vomiting 2 1 0 postoperative nausea in laparoscopic cholecystectomy19,20 .
0–24 h
≥ 1 episodes of PONV 23 23 15 0·305*
Vomiting 4 5 3 an objective registration of PONV episodes in an effort
PONV, postoperative nausea and vomiting (spontaneous complaints of
nausea, retching or vomiting); CHO, carbohydrate-rich drink. *χ2 test;
†exact binary logistic regression.
of the patients who received CHO vomited after the first
4 h, in contrast to several patients in each of the other
groups.
There were no differences between treatment groups
in VAS scores for pain or nausea before admission to
hospital or at 24 h after operation (Fig. 1). However, nausea
scores in the fasted and placebo groups were higher after
surgery than before admission (P = 0·018 and P < 0·001
respectively), whereas no significant increase was observed
in the CHO group (P = 0·082). The 13 patients who had
one or more episodes of PONV 12–24 h after operation
had significantly higher nausea scores at 24 h than the 159
who did not experience late PONV: median (interquartile
range) 43 (57) and 5 (13) mm respectively (P < 0·001).
There was no difference in preadmission nausea scores
between these subgroups (P = 0·253).
Pain scores were significantly higher after surgery
than at admission in all treatment groups (P < 0·001).
A correlation between postoperative nausea and pain was
seen in the placebo group (ρ = 0·365, P = 0·006), but not
in the two other groups.
Discussion
The odds of nausea and vomiting 12–24 h after elective
laparoscopic cholecystectomy was found to be higher in
patients who fasted overnight than in those who received
CHO. In addition, there was a significant postoperative
increase in nausea scores compared with preadmission
values in the placebo and fasted groups, but not in the
CHO group.
In the present study, such scoring was combined with
to increase the accuracy of the evaluation. Patients who
experienced late PONV (12–24 h after surgery) were found
to have significantly higher VAS scores for nausea (at 24 h)
than those who did not, supporting an association between
the two methods.
There are no generally accepted definitions of early and
late registration periods for PONV. To determine the
immediate postoperative emetic effects of anaesthesia and
surgery, an initial registration period of 4 h was chosen
for the objective assessment of nausea and vomiting.
The choice of a late registration period, 12–24 h after
surgery, was believed to be of clinical significance as
events during this period may delay discharge or necessitate
overnight admission after laparoscopic day-case surgery9 .
In the present study, three patients (1·7 per cent) could
not be discharged from hospital after 24 h owing to
intractable late PONV. None of these patients received
preoperative CHO.
Median pain and nausea scores before admission were
low. The pain scores at 24 h after surgery were higher than
expected, considering that opioids were administered to
control breakthrough pain. However, similar VAS pain
scores on the day after laparoscopic cholecystectomy
have been reported previously16,17 . An increased scatter
in nausea VAS scores was seen at 24 h. Non-parametric
ranking statistical analysis showed that nausea was worse
after surgery than before admission in the fasting and
placebo groups, but not in the CHO group. Although
significant versus non-significant differences in small
numbers of patients should be interpreted with caution,
the present data suggest that CHO might reduce nausea
and vomiting after laparoscopic cholecystectomy.
A recently published placebo-controlled study of 94
patients from Denmark16 was unable to show any signifi-
cant beneficial effects of CHO on postoperative wellbeing,
including PONV, after laparoscopic cholecystectomy16 .
Unfortunately, there was no fasting group in the Danish

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Published by John Wiley & Sons Ltd
420
investigation, which makes comparison with the present
study difficult. Furthermore, the anaesthetic protocol as
well as the registration periods and method of assessment
of PONV were different. The latter may offer some expla-
nation for the difference in the 24 h incidence of PONV
(35·5 per cent in the present study and 60·5 per cent in the
Danish study). A weakness shared by both studies is the
relatively small sample sizes (about 50 per group). With
such a small number of patients, the risk of a Type II error
increases. In the present study a significant difference in
the incidence of PONV was confirmed only between the
CHO and fasting groups 12–24 h after surgery. The lack
of significant differences between the other groups may be
related to the small sample size. Given that the incidence
of PONV would remain the same in all groups as in the
current study, a sample size of about 150 per group would
be expected to detect differences between all three groups.
The relationship between perioperative compensatory
hydration and PONV or postoperative wellbeing has not
yet been clarified23 . Although perioperative hydration was
found to reduce PONV in some recent studies24,25 , others
have found that excessive fluid administration may not only
potentially cause PONV26 but also increase morbidity26,27 .
In the present study, the intravenous infusion volumes were
about 2400 ml per 24 h in all three groups. These volumes
may seem somewhat high in the light of recent findings26 ,
but were given according to the clinical routines at the
time of the study. Such volumes may have obscured the
hydration effects of the oral fluid given before surgery in
the CHO and placebo groups.
The exact mechanism by which CHO affects PONV
needs to be clarified. The effects of its high carbohydrate
content, its distinct effects on body metabolism (insulin
release)13 and probable parallel effects on the hypothalamic
serotonin system28 require further investigation.
The present data suggest that the metabolic setting at
the onset of surgery influences late nausea and vomiting
after elective laparoscopic cholecystectomy. CHO may
therefore have a role in a multimodal approach to minimize
PONV.
Acknowledgements
The authors thank Numico Research, Wageningen,
The Netherlands, for providing the placebo and CHO
investigated. The study was supported by grants from
the Swedish Research Council (no. 09101), Karolinska
Institutet, Stockholm County Council (EXPO-95) and
from Numico Research. O.L. is the holder of a patent
for the preoperative carbohydrate drink used in this study,
Copyright  2005 British Journal of Surgery Society Ltd
Published by John Wiley & Sons Ltd
J. Hausel, J. Nygren, A. Thorell, M. Lagerkranser and O. Ljungqvist
which is licensed to Royal Numico, The Netherlands.
There was no conflict of interest for any other author.
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