To compare the ability to prevent Nausea and Vomiting by Dexmedetomidine versus its combination with Dexamethasone after surgery of the abdomen in adult patients

Phase 2

Completed

• Conditions: Nausea with vomiting, unspecified,

• Registration Number: CTRI/2021/07/035276
• Lead Sponsor: Department of Anaesthesia and Intensive Care

Brief Summary

This is a prospective and interventional randomised comparative study to compare the effect of IV Dexmedetomidine with IV Dexmedetomidine-Dexamethasone combination with Normal Saline as control in preventing PONV in patients following abdominal surgeries under general anaesthesia using a Numerical Rating Scale in 75 patients of ASA physical status I/II of either gender of 18-60 years of age. The primary outcome measured will be incidence/frequency/severity of Nausea and incidence/frequency of Vomiting at regular time intervals post-op for up to 24 hours. The secondary outcomes measured will be post-op sedation using Ramsay Sedation Scale and post-op pain using Visual Analog Scale.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-08
• Study Completion: 2021-11-23
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• ASA physical status I/II.
• Patients undergoing abdominal surgeries under general anaesthesia.

Exclusion Criteria

• Patients with previous history of post-operative nausea and vomiting, abdominal surgery, cardiovascular or cerebrovascular comorbidities, diabetes mellitus.
• Patients with history of treatment with antiemetic or glucocorticoids.
• Patients with BMI>30 kg/m2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nausea	End of surgery | 1 hour post-op | 3 hour post-op | 6 hour post-op | 9 hour post-op | 12 hour post-op | 24 hour post-op
Incidence and frequency of vomiting	End of surgery | 1 hour post-op | 3 hour post-op | 6 hour post-op | 9 hour post-op | 12 hour post-op | 24 hour post-op

Secondary Outcome Measures

Name	Time	Method
Sedation	End of surgery
Pain	End of surgery

Trial Locations

Locations (1)

Vardhman Mahavir Medical College and Safdarjung Hospital; 🇮🇳 South, DELHI, India

Vardhman Mahavir Medical College and Safdarjung Hospital

🇮🇳South, DELHI, India

Dr Meenakshi Kumar

Principal investigator

9899689829

drmeenakshi86@yahoo.com