Comparison of three anaesthesia medicines for insertion of a device into the breathing pipe in children using a brain function monitor
Phase 3
- Conditions
- Health Condition 1: Z40-Z53- Encounters for other specific health care
- Registration Number
- CTRI/2024/03/064283
- Lead Sponsor
- Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients scheduled to undergo surgery under general anaesthesia
2.Age 6 to 10 years
3.American Society of Anesthesiologists (ASA) physical status I/II
Exclusion Criteria
1.Patients with anticipated difficult airway
2.Known allergy to study drugs
3.History of seizure disorder
4.Any contraindications to the placement of supraglottic airway device
5.Refusal to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the change in the mean arterial pressure with propofol, etomidate and etofol to achieve BIS value of 50 for SAD insertion in paediatric patients aged 6 to 10 years.Timepoint: Baseline, At BIS 50,After supraglottic airway placement,1 minute after placement, 2 minutes after placement, 5 minutes after placement
- Secondary Outcome Measures
Name Time Method 1.Time taken to achieve BIS value of 50 <br/ ><br>2.Change in heart rate between the study groups <br/ ><br>3.Other side effects of intravenous study drugs (such as myoclonus, pain on injection etc) <br/ ><br>4.SAD related parameters (insertion summed score, number of attempts taken, time taken for insertion, additional study drug boluses required) <br/ ><br>Timepoint: Baseline, At BIS 50,After supraglottic airway placement,1 minute after placement, 2 minutes after placement, 5 minutes after placement