Study comparing two techniques of reducing vomiting after operation for removal of gall bladder by micro surgery where one technique is using a drug only and the other technique is using both drug and saline

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/11/060178
• Lead Sponsor: Office of the Principal Midnapore Medical College and Hospital

Brief Summary

**PROPOSED TOPIC OFRESEARCH:**  Dexamethasone VersusDexamethasone Plus Intraoperative Intravenous Ringer Lactate (30mi/Kg) Infusionto Prevent Postoperative Nausea Vomiting in Patients Undergoing LaparoscopicCholecystectomy: A Prospective, Randomised, Double Blinded Study

**OBJECTIVE OFPROPOSED RESEARCH:**

**1.**Tocompare the efficacy of dexamethasone alone & dexamethasone plusintraoperative intravenous  ringerlactate (30 ml/kg) infusion in preventing PONV in patients undergoing laparoscopiccholecystectomy operation.

2. Comparisonof analgesic requirement, rescue antiemetic requirement between the two groups.

 **Backgroundof present study**:PONV is a common complication following laparoscopic surgeries. Dexamethasonehas a prophylactic effect on PONV. This study is research of a model wheredexamethasone is combined with intraoperative fluid load of 30ml/kg inprevention of PONV in comparison with dexamethasone alone.

 **Methodology:** This study isinstitution based, prospective, randomised study on patients undergoinglaparoscopic surgery under general anaesthesia in surgery OT of MMCH. In thisstudy a total number of 100 patients who will undergo laparoscopic cholecystectomywill be taken & randomized equally in two groups. Group A set of patients willget dexamethasone (8mg) alone; whereas the group B patients will receivedexamethasone plus IV fluid load of 30ml/kg body weight. Anaesthetic &Surgical management will be standardized. The occurrence and severity of PONV& analgesic requirement in the postoperative patients will be assessed for24 hours after surgery.

 **Expected outcome:** As we are usingequipotent doses of dexamethasone (8mg) in both sets of patients but usingliberal fluid (30ml/kg) in excess for the group B patients; we are expectingthat incidence & severity of PONV will significantly decrease in the groupB.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-11-21
• Study Start: 2024-02-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

ASA 1 and 2 Posted for elective laparoscopic cholecystectomy.

Exclusion Criteria

Severe Cardiopulmonary disease Hepatic and Renal Failure Neurologic disorder Endocrine disorder Not given Consent Psychiatric Problem Allergy to dexamethasone.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study and know about the efficacy of Dexamethasone plus intraoperative fluid load of 30ml/kg in preventing post operative nausea and vomiting when compared with Dexamethasone alone	2hour, 4 hour, 6 hour, 12 hour, 18 hour, 24 hour after completion of surgery

Secondary Outcome Measures

Name	Time	Method
1. To compare the requirement of rescue antiemetic between two groups	2. To compare the requirement of rescue analgesic during the first 24hr.

Trial Locations

Locations (1)

Midnapore Medical College and Hospital; 🇮🇳 Medinipur, WEST BENGAL, India

Midnapore Medical College and Hospital

🇮🇳Medinipur, WEST BENGAL, India

Dr Kuldip batabyal

Principal investigator

7908000122

kuldipbatabyal@gmail.com