Nabil A. Jayousi,
MD*, Reham I. Sha'ban, MD**
* From the Department
of Anaesthesia in King Hussein Medical
Center in Royal Medical Services.
** From the Department of Ophthalmology
in King Hussein Medical Center in
Royal Medical Services, vitreoretinal
surgeon.
Dr. Nabil Jayousi,
Consultant, Head of Anaesthesia section
in Ophthalmology Department.
E-mail: njayousi2000@yahoo.com.
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ABSTRACT
Aim: To investigate
the efficacy and safety of low dose
of droperidol for the prophylaxis
of post-operative nausea and vomiting
following vitrectomy in diabetic patients.
Design and Settings: Randomised
placebo controlled double blinded
study conducted in the Department
of Ophthalmology, King Hussein Medical
Center in Royal Medical Services.
Methods: Patients with proliferative
diabetic retinopathy scheduled for
pars plana vitrectomy were randomised
either to receive droperidol 10ug/kg
5-10 minutes at the end of surgery
or saline (placebo) as a control group.
120 patients were enrolled in the
study; 58 males and 62 females aging
40-78 years. Standardised general
anaesthesia was performed. Thiopentone
4mg/kg, vecuronium 0.1mg/kg, fentanyl
1ug/kg was given intravenously combined
with ventilated sevoflurane 1% through
laryngeal mask. Tidal volume was 7ml/kg
and respiratory rate was 10/minute.
Episodes of vomiting, nausea and retching
were recorded for 24 hours and were
graded into none, mild, moderate,
and severe.
Results: 45 patients (75%)
of group receiving droperidol did
not experience post operative nausea
or vomiting while 41.7% of the control
group experienced it. There were no
significant extrapyramidal or cardiac
side effects in the droperidol group.
Conclusion: Low dose droperidol
is considered to be effective and
safe in vitreoretinal surgery.
Key words: Anti-emetic, Droperidol,
Vitrectomy, nausea and vomiting.
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Post operative nausea and
vomiting (PONV) has significant impact on
patients and heath care providers 1. Despite
impressive advances in the field of anaesthesia
20-30% of patients continue to experience
PONV within the first 24 hours 2.
The vomiting reflex may be
excited by many stimuli most of which are
operative 3. Some of the factors associated
with PONV are patient predisposition, surgical
site related, opiods administration and
anaesthetic drugs used. Ophthalmic surgeries
are associated with increased incidence
of nausea and vomiting 4. Nausea and vomiting
can induce ketosis in diabetic patients
undergoing vitrectomy for advanced diabetic
retinopathy 5.
Droperidol is frequently used
in the United States of America and Europe
as a prophylactic drug against PONV 6-7.
It is a well-tolerated drug, inexpensive,
and has few side effects. The Food and Drug
Administration had mandated that the manufacture
or the generic formulation of droperidol
place a black box warning regarding the
risk of serious proarrhythmogenic effects 8.
The aim of this study was
to study the safety and efficacy of droperidol
in relieving PONV in diabetic patients undergoing
pars plana vitrectomy.
A prospective randomised
double blind study. 120 patients were enrolled
in the study. All of them underwent pars
plana vitrectomy at King Hussein Medical
Center, Ophthalmology Department in the
period between May 2004 and October 2005.
All patients had standard three port pars
plana vitrectomy due to advanced diabetic
retinopathy. Patients were divided into
two groups; the first group was given low
dose droperidol (10 micrograms/kg diluted
in 10 millilitres normal saline 0.9%) ten
minutes before the end of surgery. The control
group was given 10 millilitres of normal
saline 0.9% as a placebo.
Randomisation was done by
sealed envelope technique. Patients receiving
antiemetic or patients who were suffering
from nausea or vomiting during the last
two weeks before surgery were excluded from
the study. All patients fasted starting
from 10 pm, the night before the surgery.
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General anaesthesia was standardised.
After insertion of an intravenous line,
fentanyl (1-2 microgram/kg) and propofol
(2mg/kg) were used for induction. Laryngeal
mask was used and vecuronium (0.1mg/kg)
was used as muscle relaxant. Neuromuscular
monitoring was done. Drugs were repeated
as indicated to reduce the need for an antagonising
neuromuscular agent (atropine 0.5mg and
neostigmine 0.1mg/kg). Anesthesia was maintained
using sevoflurane at an end expiratory concentration
of 1%. The lungs were ventilated with O2/N2O
in a fraction of 0.3: 0.7 using fresh gas
flow at 1 litre /minute. Ventilation was
adjusted to keep end tidal carbon dioxide
within the normal range (36-40mmHg). No
local anaesthesia was given by the surgeon.
Vital signs were regularly
monitored. Two hours after recovery, patients
were transferred to the surgical word. Patients
were monitored for the occurrence of nausea
and emetic episodes defined as retching
or vomiting at 2, 4, 6, 12, 24 hours. Medical
records were screened for PONV. Nausea and
vomiting was assessed on a rating scale
as: 0 - no nausea, no vomiting, 1 - nausea
without vomiting (mild), 2 -nausea with
vomiting less than three times (moderate),
3 -nausea with vomiting more than three
times (severe).
120 patients
were enrolled in the study. The mean age
was 66.4 years. Females slightly outnumbered
males (62 vs. 58).
Table I
shows demographic data and patient characteristics.
There is no relevant difference among the
groups.
The number of patients suffering
from nausea and vomiting was significantly
lower in the droperidol group than in the
placebo group (25% vs. 38.3%, P value <
0.01).
Table III
shows the incidence of side effects. There
was no increase in the incidence of arrhythmias
or cardiovascular side effects with droperidol.
0.5% of the droperidol group experienced
mild restlessness. Headache was more frequent
in the placebo group. Intraocular bleeding
was diagnosed in three patients in the droperidol
group and five patients in the placebo group.
Opiods were not used
as they may sensitise the vestibular apparatus
and affect the incidence of postoperative
nausea and vomiting 9.
In this study droperidol
has been shown to be effective in reducing
PONV in vitreoretinal surgery compared with
placebo. This is in accordance with previous
studies in ophthalmic surgery 10-11. More
patients in the control group experienced
PONV; this was statically significant (p
value < 0.01). The incidence of severe
nausea and vomiting was 5% in the droperidol
group and 13.3% in the placebo group. (See
Table II for more
details).
There were no significant side effects including
neurological and extrapyramidal problems.
Restlessness, though, was more prevalent
in the droperidol group but it was not statically
significant (0.3<p<0.5). Headache
was significantly less in the droperidol
group (0.05<p<0.02); this was true
for mild to moderate headache but not for
severe headache. Droperidol seemed to be
protective against headache.
As the Food and Drug
Administration mandates that manufactures
droperidol place black box warning regarding
the risk of proarrhythmogenic effects. We
observed patients thoroughly for cardiac
side effects. There was no significant difference
in cardiac status among the two groups.
Our results confirmed what was reported
in a study done by Henzi and his colleagues
12.
All patients who had
postoperative intraocular bleeding had PONV
or retching. Patients with intraocular bleeding
who didn't receive droperidol slightly outnumbered
those who received it but this was not significant
(0.3<p<0.5).
In conclusion, droperidol is a cost effective
drug compared with other antiemetic therapy
13. It is considered to be an efficacious
and safe drug to be used in patients undergoing
vitreoretinal surgery.
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