Post operative dexmedetomidine nebulization for post operative pain management

Phase 3

Not yet recruiting

• Conditions: Cholelithiasis,

• Registration Number: CTRI/2023/09/057764
• Lead Sponsor: DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES

Brief Summary

This study is a randomised controlled trial, double blind study, checking the efficacy of post operative nebulization of Dexmedetomidine as an analgesic adjunct in a patients of laparoscopic cholecytectomy.

Patients are divided into 2 groups. Group A patients are nebulized with dexmedetomidine with the dose of 2mcg/kg (total of 5 ml). Group B patients are nebulized with 5 ml of normal saline.

Our primary objective is to compare the pain score (NRS) at 15, 30 mins, 1, 2, 6, 12, 24 hr and total dose of rescue Analgesia (Tramadol) used in both groups in first 24 hour. Secondary objective is to compare sedation score (Ramsay), incidence of delirium and post operative sore throat in both the groups.

Inclusion criteria include ASA Physical status I and II, 18 to 65 years of either sex, Weight of 45 to 90 kg, Height of 150 to 180cms and Patients undergoing elective laparoscopic cholecystectomy surgery.

Exclusion criteria include ASA Physical status III and IV, Patient unwilling, Haemodynamically unstable patients, Duration of surgery exceeding more than 2 hour, History of any allergy to general anesthetic agents, Significant history of drug/alcohol abuse, Patients with comorbidities (hypertension, diabetes), conversion of laproscopic cholecytectomy to open cholecytectomy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-15
• Study Start: 2023-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• ASA Physical status I and II.
• Weight of 45 to 90 kg.
• Height of 150 to 180 cms.
• Patients undergoing elective laparoscopic cholecystectomy surgery.

Exclusion Criteria

• ASA Physical status III and IV.
• Patient unwilling.
• Haemodynamically unstable patients.
• Duration of surgery exceeding more than 2 hour.
• History of any allergy to general anaesthetic agents.
• Significant history of drug/alcohol abuse.
• Patients with comorbidities (hypertension, diabetes).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the pain scores (NRS) in both group	To compare the pain scores (NRS) in both group within 24 hours, namely at 15 mins, 30 mins, 1 hr, 2 hr, 6 hr, 12 hr, 24 hr. | To compare the total dose of rescue analgesia used in both groups, within 24 hours.
To compare the total dose of rescue analgesia used in both groups.	To compare the pain scores (NRS) in both group within 24 hours, namely at 15 mins, 30 mins, 1 hr, 2 hr, 6 hr, 12 hr, 24 hr. | To compare the total dose of rescue analgesia used in both groups, within 24 hours.

Secondary Outcome Measures

Name	Time	Method
Sedation score (Ramsay) in both the group	Incidence of delirium in both the group

Trial Locations

Locations (1)

RAJENDRA INSTITUTE OF MEDICAL SCIENCES; 🇮🇳 Ranchi, JHARKHAND, India

RAJENDRA INSTITUTE OF MEDICAL SCIENCES

🇮🇳Ranchi, JHARKHAND, India

DR DEEPAK HANSDAH

Principal investigator

09931111738

deep1738@gmail.com