A STUDY TO COMPARE THE EFFECT OF INJECTION RAMOSETRON AND ONDANSETRON IN PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC GYNAECOLOGICAL PROCEDURES

Completed

• Conditions: ASA grade 1 and 2

• Registration Number: CTRI/2018/05/014278
• Lead Sponsor: Lady Hardinge Medical College and associate hospitals new delhi

Brief Summary

The present study was undertaken in theDepartment of Anaesthesiology, Lady Hardinge Medical College & Smt. SuchetaKriplani Hospital, New Delhi, after approval by the institutional ethical committeeto study the effect of ramosetron and ondansetron in prevention ofpostoperative nausea and vomiting in patients undergoing laparoscopicgynaecological procedures. The study was conducted in female patients (ASAgrade I & II)  posted for electivelaparoscopic gynaecological procedures under general anaesthesia. Our aim wasto compare the effect of intravenous ramosetron and ondansetron in preventionof postoperative nausea and vomiting. Our primary objective was to study theincidences of postoperative nausea and vomiting (PONV). Secondary objectiveswere to know the time of occurrence offirst episode of  post operative nauseaand vomiting(PONV) in both the groups, the need of rescue antiemetics, patientsatisfaction score and to look for any side effects.Exclusioncriteriaof our study included refusal by the patient, h/o motion sickness, antiemeticmedication in 24hr before surgery, patients with complaint of preoperativenausea and vomiting and h/o allergy to any drug.

Patientsunderwent a thorough preoperative assessment, informed written consent wastaken.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 withnormal saline.

**Group R (Ramosetron):** patientsreceived 0.3 mg (0.3mg/ml)i.v diluted to volume of 5 ml with normal saline.

Allpatients were kept fasting overnight. A uniform premedication and generalanaesthesia technique was used for all the patients.

Followingobservations were made:

1.     Number of nausea andvomiting episodes at the intervals of: 0-2hrs,2-6hrs,6-12hrs and 12-24hrs.

2.     Time of occurance offirst 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 byusing a numeric scoring system8

0 = no nauseaor vomiting

1 = nauseaalone

2 = vomitingonce

3 =vomiting twoor more times in 30 minutes

SeverePONV is defined as a PONV score of 3 or persistent nausea (>2 hours) andwill be treated with rescue antiemetic inj. metoclopramide 10 mg.  Retching was not be considered a separateentity. Patient who report retching were classified as nausea.

4.     Patients satisfactionwith 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 eventsthroughout the 24 hours of duration in post-operative period(end point).

6.     All the data werecollected and analyzed statistically using computer software SPSS version 15.0.Quantitative study was done by using Unpaired Student T-Test and Mann-WhitneyTest. 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 wasconsidered as significant.

 **Following Conclusions were drawnfrom the observation of our study:**

 1.     Incidence of PONVafter general anaesthesia in patients undergoing gynaecological procedures was  53%.

2.     The overall incidenceof PONV was 52% in ondansetron group and 56% in ramosetron group. Thisdifference was not significant statistically.

3.     The time of firstepisode of PONV was same in patient who received either ondansetron orramosetron.

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 wasconcerned, none of the patients had a score of 3 at any point of time. Bothramosetron and ondansetron group had similar effect in reducing the severity.

6.     No significant differencewas found in  complete treatment responsebetween ondansetron and ramosetron group at any time interval.

7.     Requirement of rescueantiemetic was more in ondansetron group during 2-6 hrs and 6-12 hrs, howeverthis difference was insignificant statistically.

8.     Patients reportedequal satisfaction in both ondansetron and ramosetron group during 0-24 hrsafter surgery.

9.     No serious sideeffects were seen in the 24 hrs postoperative period with the use of ondansetronor ramosetron.

 **Thusfrom our study, we conclude that ramosetron is as effective as ondansetron inpreventing the incidence and severity of PONV. Though, we are still far fromthe goal of achieving zero incidence of PONV, it is worthwhile to use aprophylactic antiemetic as it has a favourable influence on patientsatisfaction. Further studies are needed to know the longer acting, moreefficient combinations of drugs which can act on more than one receptor toblock the emetic reflex.**

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-12
• Study Completion: 2015-04-30
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

ASA grade 1&2 undergoing laparoscopic gynaecological procedure.

Exclusion Criteria

1.refusal by patient 2.history of motion sickness 3.history of antiemetic medication in last 24 hours 4.complaint of preoperative nausea and vomiting 5.allergy of any drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of episodes of nausea and vomiting	Number of episodes of nausea and vomiting in postoperative period 0-2 hrs, 2-6 hrs,6-12 hrs, 12-24 hrs

Secondary Outcome Measures

Name	Time	Method
1.Time of occurrence of first episode of post operative nausea and vomiting (PONV) in both the groups.	2. Compare the need of rescue antiemetics in both groups.

Trial Locations

Locations (1)

LADY HARDINGE MEDICAL COLLEGE; 🇮🇳 Delhi, DELHI, India

LADY HARDINGE MEDICAL COLLEGE

🇮🇳Delhi, DELHI, India

DR SASHMITA DAS

Principal investigator

7838806766

sashdas20@gmail.com