A clinical trial comparing the effect of two drugs namely dexmedetomidine and ketamine through nebulization given prior to surgery in children

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/11/038096
• Lead Sponsor: Department of Anaesthesia and intensive care VMMC and Safdarjung hospital

Brief Summary

This study is a randomized, participant blinded, parallel group study comparing two groups of 30 children each undergoing elective surgery under general anaesthesia, who are nebulized either with dexmedetomidine, or ketamine as premedication. The study will be conducted in VMMC and Safdarjung hospital, New Delhi. The primary outcome of the study is level of sedation on arrival in operation room after being nebulized with study drug. The secondary outcomes are parental separation, mask acceptance and recovery after nebulization with study drug.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-08-11
• Study Start: 2021-12-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age group:3 to 10 years Elective surgery under general anaesthesia.
• American society of Anaesthesiologist’s grade I and grade II Normal airway.

Exclusion Criteria

• Active upper respiratory tract infection Patients with known allergy to study drug.
• Patients with significant organ dysfunction.
• Patients with cardiac dysrhythmias, congenital heart disease Patients using psychotropic medication.
• Patients with intellectual disability.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of sedation	Preoperative | Baseline, 5minutes, 10 minutes, 20 minutes, 30 minutes, Intra operative at beginning of surgery

Secondary Outcome Measures

Name	Time	Method
Parental separation	Mask acceptance

Trial Locations

Locations (1)

VMMC and Safdarjung hospital; 🇮🇳 South, DELHI, India

VMMC and Safdarjung hospital

🇮🇳South, DELHI, India

Kalwal Vijaya laxmi

Principal investigator

8595989912

vijji.kalwal@gmail.com