A study comparing ability of palanosetron and ondansetron with dexamethasone in preventing post operative vomiting after laparascopic surgeries

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/10/046442
• Lead Sponsor: Sri Venkateswaraa medical college hospital and research center

Brief Summary

This study aims to compare the efficacy of Palonosetron versus ondansetron and dexamethasone combination as prophylaxis for prevention of postoperative nausea and vomiting after laparoscopic surgeries. This study will be done after CTRI registry and clearance. Subjectwill be recruited based on inclusion and exclusion criteria. A written informed consent will beobtained from all the subjects.A detailed medical history will be obtained from all the subjects. To do this study patients will beasked to follow some prerequisites according to standard anesthetic protocol. On the day ofsurgery, Patient will be shifted to OT-complex and an IV cannula will be inserted in patient hand,through which the study drug will be given.These drugs injected intravenously will anaesthetize and study drug will prevent nausea andvomiting intraoperatively and postoperatively. After surgery patient will be shifted to recovery,continuously monitored, and any complications occurring during this period will also be treatedaccordingly.If the patient decide to participate in this research, He /She will be placed in the group according torandomization and patient may get either of the drugs during surgical procedure, if the drugs failrescue antiemetic will be given and it will be noted. Patients will be followed up in the post operative ward for first 48hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who give valid inform consent and willing to participate in the study 1) ASA grade I/II patients 2) age group of 18 to 60 years scheduled to undergo elective laparoscopic surgeries, under general anaesthesia.

Exclusion Criteria

Patient refusing to participate in the study 1) Any contraindication to the use of drug 2)BMI >35kg/m2 3) ASA III or more, 4) emergency procedure 5) Pregnant and lactating patients • Patients with history of motion sickness • Patients on steroid therapy, antiemetics or on treatment with other medication known to produce nausea and vomiting.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
asses incidence of post operative nausea and vomitting for 48 hours	0mins,30mins,60mins,2hrs,4hrs,6hrs,8hrs,10hrs,12hrs,16hrs,20hrs,24hrs,36hrs,48hrs

Secondary Outcome Measures

Name	Time	Method
requirement of rescue anti emetic	48 hours post operative period

Trial Locations

Locations (1)

Sri Venkateshwaraa medical college hospital and research center; 🇮🇳 Pondicherry, PONDICHERRY, India

Sri Venkateshwaraa medical college hospital and research center

🇮🇳Pondicherry, PONDICHERRY, India

Deepak krishnan

Principal investigator

7200040440

dr.deepakkrishnan@gmail.com