Indian

A. J. Anaesth.
RUDRA, MANDAL, 2005; 49 (2) : KUMAR
P. RUDRA, 109 - 112
: DROPERIDOL AND METOCLOPRAMIDE IN PONV OF LAPAROSCOPY 109

COMPARISON OF DROPERIDOL AND METOCLOPRAMIDE

IN THE PREVENTION OF NAUSEA – VOMITING AFTER
LAPAROSCOPIC CHOLECYSTECTOMY
Dr. Rudra A. 1 Dr. Mandal M. 2 Dr. Rudra P. 3 Dr. Kumar P. 4

SUMMARY
Patients undergoing laparoscopic cholecystectomy (LC) may be especially at risk of experiencing postoperative nausea and vomiting
(PONV). The aim of the study was to evaluate and compare the antiemetic efficacy of droperidol and metoclopramide when administered
prophylactically for prevention of PONV after LC. 5 minutes prior to induction of anaesthesia, 90 patients received in a randomized,
double blind manner, inj. droperidol 20 mgkg-1 or inj. metoclopramide 0.2 mgkg-1 or placebo (n = 30 per group) intravenously. Patients
were then observed for the next 24 hr after administration. During 24 hours after LC, the percentage of patients free of nausea vomiting
were 58% with droperidol, 52% with metoclopramide and 46% with placebo. There were no significant differences between the groups.
The overall risk of adverse events did not differ in any of the groups, except dry mouth/lips in droperidol group compared with
metoclopramide and placebo (P < 0.05). The results in our study suggests that droperidol and metoclopramide when administered
prophylactically before induction of balanced general anaesthesia were not significantly effective to control PONV in LC in comparison
to placebo.
Keywords : Vomiting : Nausea, Anti–emetics, Pharmacology: Droperidol, Metoclopramide, Surgery:
Laparoscopic cholecystectomy.

Introduction However, many trials have concluded that droperidol and

Postoperative nausea and vomiting (PONV) are metoclopramide does not have significant undesirable
distressing and common adverse events after general effects when used for prophylaxis of postoperative
anaesthesia and surgery1,2,3 and has been called the “big nausea and vomiting.13-15 This study was undertaken in a
little problem”.4 The incidence of PONV has been reported randomized, double blind manner, to compare the antiemetic
high with no antiemetic treatment in patients undergoing efficacy of a single intravenous dose of droperidol or
metoclopramide after tracheal extubation in the
laparoscopic cholecystectomy (LC).5,6,7 PONV not only
prevention of PONV after LC.
causes discomfort to the patients but also leads to
complications including electrolyte imbalance, regurgitation Methods
and aspiration, increased bleeding and wound dehiscence.8
Institutional ethics committee approval and informed
Moreover, patients who suffer from PONV require additional consent from each patient were obtained, and 90 women
healthcare professional time and material resources aged 20 – 60 years, who were classified as ASA grade I or
leading to higher costs. Hence, prophylactic antiemetic II were included in the study. Patients with gastrointestinal
therapy is needed for these patients. disease, history of motion sickness and/or previous
PONV, pregnancy or menstruation, or those who had taken
Droperidol administered in small doses before
antiemetics within 24 hour before operation were excluded
anaesthesia or intraoperatively have been claimed to be an
from the study.
effective antiemetic.9 However, there is concern that
droperidol may prolong recovery. Metoclopramide has On arrival to the operation theatre, routine monitoring
also been reported to reduce the incidence of PONV10-12 devices were attached and SpO2, heart rate, ECG, NIBP,
but the agent may cause extrapyramidal side effects. and ETCO2 were observed throughout the study period.
No patients received preanaesthetic medication. Anaesthesia
1. M.D., FAMS. Prof. was induced with inj. fentanyl 2 mgkg-1 and inj. thiopentone
2. M.B.B.S., PG student sodium 5 mgkg-1. Intubation was facilitated by inj. vecuronium
3. M.B.B.S., PG student 0.15 mgkg-1 anaesthesia was maintained with halothane 1%
4. M.B.B.S., PG student (inspired concentration), nitrous oxide 60% in oxygen with
Calcutta National Medical College, Kolkata
controlled ventilation to maintain end tidal carbon dioxide
Correspond to :
Dr. A. Rudra between 4.6 and 5.2 kpa throughout the procedure. Muscle
(Accepted for publication on 19-1-2005 ) relaxation for pneumoperitoneum and surgical procedures
110 INDIAN JOURNAL OF ANAESTHESIA, APRIL 2005

was provided with additional doses of vecuronium. A that (a) complete control of PONV would be achieved in
nasogastric tube was placed and suction was applied to 50% of patients receiving placebo, (b) an improvement
empty the stomach of air and other contents. The nasogastric from 50 – 72% was considered to be of clinical importance
tube was removed at the completion of surgery and before and (c) a = 0.05 and a power (1-b) of 80%. Based on these
tracheal extubation. assumptions 30 patients per group was required.
Abdominal insufflation for the laparoscopic Results
procedure was achieved with CO2 and intraabdominal
The treatment groups were comparable with regard
pressure was maintained between 1.3 – 1.8 kpa. At the end
to patient demographics (table 1). Complete control of
of surgery residual neuromuscular blockade was antagonized
established PONV (no emesis, no rescue) for 24 hours after
by inj. atropine 0.02 mgkg-1, inj. neostigmine 0.05 mgkg-1
administration of the study agent was achieved in 58 per
and the trachea was extubated. After extubation, based on
cent of patients with droperidol, 52 per cent of patients
the randomization table, patients were allocated in equal
with metoclopramide and 46 per cent with placebo. The
numbers into 3 groups of 30 patients each to receive
differences were not significant between the groups (fig. 1).
intravenously either inj. droperidol 20 mgkg-1 or inj.
metoclopramide 0.2 mgkg-1 or normal saline 2 ml as placebo.
Table - 1 : Demographic data (mean±SD).
Postoperative pain relief was provided with inj. pethidine
1.5 mgkg-1 intramuscularly when pain score was ³ 5 (VAS). Droperidol Metoclopramide Placebo
All patients received supplementation of moist oxygen 4 (n=30) (n=30) (n=30)
lmin-1 via hudson’s facemask in the postoperative period for
Age (years) 40±13 41±14 42±13
4 hours and were monitored continuously in the recovery
room. Patients and investigators who collected postoperative Weight (kg) 61±10 61±10 64±10
data were blinded to the study drug administered.
Episodes of nausea and vomiting were determined
and noted in the first 24 hrs after operation at different 60

intervals: 0–4 hours, 4–8 hours, 8–16 hours and 16–24 hours. 50

At the end of each interval, an anaesthesiologist registered

whether vomiting had occurred and asked the patients 40

whether they felt nauseated. The results were scored in a Nausea

% 30
manner similar to Belville et al16 (0=none, 1=nausea/ Vomiting

retching, 2=vomiting). Nausea was defined as a subjectively 20

unpleasant sensation associated with the urge to vomit,

10
retching was defined as the laboured, spasmodic,
rhythmic contraction of the respiratory muscles without 0

expulsion of the gastric contents and vomiting was defined Droperidol Metoclopramide Placebo

as the forceful expulsion of gastric contents.1 Patients who

Fig. 1 : Incidence of nausea and vomiting.
experienced 2 or more emetic episodes were given inj.
granisetron 40 mgkg-1 intravenously as rescue antiemetic.
Patients who received rescue antiemetic were classified as Certain undersitable events like headache, dizziness,
treatment failure, and were considered to experience both restlessness and drymouth/lip were noted among both groups
nausea and vomiting. (table 2).
Side effects were registered during the initial 2 hours
Table 2 : Undesirable events.
after completion of surgery in the recovery room after
monitoring the patient’s for headache, dizziness, dry mouth/ Droperidol Metoclopramide Placebo
lips, restlessness. During the subsequent 22 hours in the (n=30) (n=30) (n=30)

ward, these functions were monitored every 2 hours. Headache 2 (6%) 1 (3%) 0

Data were analyzed using chi – square test and one Dizziness 5 (15%) 1 (3%) 1 (3%)
way analysis of variance, including duncan’s multiple Dry mouth/lip 6 (18%)* 0 0
range tests. Differences were considered significant
Restlessness 2 (6%) 1 (3%) 0
when P < 0.05. Power analysis was used to determine the
number of patients in the study based on the assumption *P < 0.05
A. RUDRA, MANDAL, P. RUDRA, KUMAR : DROPERIDOL AND METOCLOPRAMIDE IN PONV OF LAPAROSCOPY 111

oxygen with 4 litres via a Hudson’s mask after surgery.

In the current study, atropine was used along with
neostigmine to ameliorate the emetic episodes produced
by neostigmine. Atropine is a tertiary amine, that cross
the blood brain barrier and reduce PONV.25 Therefore,
the difference in control of PONV (no emesis, no rescue)
can be attributed to the study drug administered.
Previous studies had claimed that droperidol
Fig. 2 : Postoperative emetic score as a function of time after balanced administered prophylactically in doses of 0.25 – 5 mg was
general anaesthesia in patients undergoing laparoscopic cholecystectomy
an effective antiemetic.9,17,18,26,27 However, the observed
results in our study with 20 mgkg-1 of droperidol I.V. were
2 patients in droperidol group and 1 patient in ineffective in controlling PONV after LC. An increased
metoclopramide group complained of headache. 5 patients dose of droperidol was not given because of the recently
of droperidol group, 1 patient of metoclopramide and reported high association with morbidity and mortality due
placebo group complained of dizziness. Restlessness was to cardiac cause.
observed in 2 patients in droperidol group and 1 patient
The efficacy of metoclopramide in controlling
in metoclopramide group. However, dry mouth/lip
PONV is controversial. The results of previous studies
was complained by 6 patients only in droperidol group
suggested that prophylactic administration of 20 mg of
(P < 0.05).
metoclopramide intravenously could prevent PONV.10-12
Discussion However, in our institution, metoclopramide has been
used with success for last few years against PONV except
Postoperative nausea and vomiting is among the
in LC in the dose of 0.2 mgkg-1 with an acceptable level
most common complications following anaesthesia and
of adverse effects. The efficacy of low dose metoclopramide
surgery, with a relatively high incidence after laparoscopic
may be its effects on central dopaminergic action and on
cholecystectomy.1-7 The aetiology behind the postoperative
5-HT3 receptors.12 But the results of current study showed
nausea and vomiting following laparoscopic cholecystectomy
that, metoclopramide 0.2 mgkg-1 given intravenously after
are complex and multifactorial and is dependant on a variety
extubation of trachea was not effective significantly in
of factors, including patient demographics, type of surgery,
comparison with placebo (p > 0.05), which corroborate the
anaesthetic technique and postoperative care.1 Patient related
results of Piper et al.21
factors are age, sex, obesity, a history of motion sickness,
menstrual cycle, and/or previous postoperative nausea Our results with droperidol and metoclopramide
and vomiting. In this clinical trial, however, the treatment are in agreement with the study results of Fujii et al.22
groups were similar with respect to patient demographics, Furthermore, droperidol 20 mgkg-1, and metoclopramide
operative management, and patient related factors. 0.2 mgkg-1 have been used for the control of PONV after
Otherwise, the number of patients who were observed to be LC22 and were also used in the present study.
emesis free in the present study would have been changed
Adverse events observed in this study were not
if such patient related factors had not been controlled. All
serious. Moreover, the overall incidence of adverse events
patients were anaesthetised and operated by the same
were similar among the 3 study groups, except complaint
team of anaesthesiologists and surgeons. Duration and the
of dry mouth/lips significantly more in droperidol group
agents used in anaesthesia were similar in both groups.
than in other study group (p < 0.05).
Furthermore, the duration of surgery was also similar in
both the groups. Nitrous oxide used in anaesthesia might In conclusion, neither droperidol 20 mgkg-1 nor
be considered to influence PONV due to the diffusion of metoclopramide 0.2 mgkg-1 were effective in comparison
the agent to the middle ear and bowel, resulting in with placebo in controlling PONV when used prophylactically
activation of the medullary dopaminergic system, and in patients undergoing general anaesthesia for laparoscopic
increased endogenous cerebrospinal opioids.23 However, cholecystectomy. However, we have studied with low dose
Grief et al24 commented in their study that, patients breathe of droperidol 20 mgkg-1 still, the recent reports of serious
a higher inspired oxygen concentration during the cardiac complications associated with the drug prevent us
perioperative period would have lower incidence of to recommend for the further study with the agent either as
PONV. In this clinical study, all patients get supplemental prophylactic or rescue medicine in PONV.
112 INDIAN JOURNAL OF ANAESTHESIA, APRIL 2005

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