| The present study was undertaken in the
Department of Anaesthesiology, Lady Hardinge Medical College & Smt. Sucheta
Kriplani Hospital, New Delhi, after approval by the institutional ethical committee
to study the effect of ramosetron and ondansetron in prevention of
postoperative nausea and vomiting in patients undergoing laparoscopic
gynaecological procedures. The study was conducted in female patients (ASA
grade I & II) posted for elective
laparoscopic gynaecological procedures under general anaesthesia. Our aim was
to compare the effect of intravenous ramosetron and ondansetron in prevention
of postoperative nausea and vomiting. Our primary objective was to study the
incidences of postoperative nausea and vomiting (PONV). Secondary objectives
were to know the time of occurrence of
first episode of post operative nausea
and vomiting(PONV) in both the groups, the need of rescue antiemetics, patient
satisfaction score and to look for any side effects. Exclusion
criteria
of our study included refusal by the patient, h/o motion sickness, antiemetic
medication in 24hr before surgery, patients with complaint of preoperative
nausea and vomiting and h/o allergy to any drug.
Patients
underwent a thorough preoperative assessment, informed written consent was
taken.
Patient were categorized into two groups, i.e group R and group O.
Group O (Ondansetron):
patients received 8mg(2mg/ml) i.v of ondansetron diluted to volume of 5 ml with
normal saline.
Group R (Ramosetron): patients
received 0.3 mg (0.3mg/ml)i.v diluted to volume of 5 ml with normal saline.
All
patients were kept fasting overnight. A uniform premedication and general
anaesthesia technique was used for all the patients.
Following
observations were made:
1.
Number of nausea and
vomiting episodes at the intervals of:
0-2hrs,2-6hrs,6-12hrs and 12-24hrs.
2.
Time of occurance of
first episode of nausea and vomiting.
Observation 1 and 2 were also be subgrouped into early
(0-6hrs) and late (6-24hrs) post operative period.
3.
PONV was evaluated by
using a numeric scoring system8
0 = no nausea
or vomiting
1 = nausea
alone
2 = vomiting
once
3 =vomiting two
or more times in 30 minutes
Severe
PONV is defined as a PONV score of 3 or persistent nausea (>2 hours) and
will be treated with rescue antiemetic inj. metoclopramide 10 mg. Retching was not be considered a separate
entity. Patient who report retching were classified as nausea.
4.
Patients satisfaction
with the study medication were assessed using a five-point scale37,
24 hours after the end of drug administration as:
1: very satisfied
2: quite satisfied
3: neither satisfied nor unsatisified
4: rather unsatisfied
5: very unsatisfied
5.
Adverse events
throughout the 24 hours of duration in post-operative period(end point).
6.
All the data were
collected and analyzed statistically using computer software SPSS version 15.0.
Quantitative study was done by using Unpaired Student T-Test and Mann-Whitney
Test. Qualitative study was done by using Chi-Square Test and Fisher Test.
Results were presented as mean ± S.D or percentage. p value of < 0.05 was
considered as significant.
Following Conclusions were drawn
from the observation of our study:
1.
Incidence of PONV
after general anaesthesia in patients undergoing gynaecological procedures was 53%.
2.
The overall incidence
of PONV was 52% in ondansetron group and 56% in ramosetron group. This
difference was not significant statistically.
3.
The time of first
episode of PONV was same in patient who received either ondansetron or
ramosetron.
4.
During early (0-6hrs)
postoperative period, incidence of PONV was more (51%) as compared to late (6-24hrs)
postoperative period (13%).This difference was significant statistically.
5.
As far as reduction in severity of PONV was
concerned, none of the patients had a score of 3 at any point of time. Both
ramosetron and ondansetron group had similar effect in reducing the severity.
6.
No significant difference
was found in complete treatment response
between ondansetron and ramosetron group at any time interval.
7.
Requirement of rescue
antiemetic was more in ondansetron group during 2-6 hrs and 6-12 hrs, however
this difference was insignificant statistically.
8.
Patients reported
equal satisfaction in both ondansetron and ramosetron group during 0-24 hrs
after surgery.
9.
No serious side
effects were seen in the 24 hrs postoperative period with the use of ondansetron
or ramosetron.
Thus
from our study, we conclude that ramosetron is as effective as ondansetron in
preventing the incidence and severity of PONV. Though, we are still far from
the goal of achieving zero incidence of PONV, it is worthwhile to use a
prophylactic antiemetic as it has a favourable influence on patient
satisfaction. Further studies are needed to know the longer acting, more
efficient combinations of drugs which can act on more than one receptor to
block the emetic reflex. |