Comparison of three anaesthesia medicines for insertion of a device into the breathing pipe in children using a brain function monitor

Comparison of bispectral index guided propofol, etomidate and etofol infusion for supraglottic airway device insertion in paediatric patients: a randomised controlled trial - Nil

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064283

Enrollment

132

Registered

2024-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z40-Z53- Encounters for other specific health care

Interventions

Intervention1: Etomidate arm: Etomidate (2mg/ml) at an infusion rate of 200ml/hour Intervention2: Propofol-etomidate arm: 1:1 combination of the propofol (10mg/ml) and etomidate (2mg/ml) at an infusio

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Time taken to achieve BIS value of 50 2. Change in heart rate between the study groups 3. Other side effects of intravenous study drugs (such as myoclonus, pain on injection etc) 4. SAD related parameters (insertion summed score, number of attempts taken, time taken for insertion, additional study drug boluses required) Timepoint: Baseline, At BIS 50, After supraglottic airway placement,1 minute after placement, 2 minutes after placement, 5 minutes after placement	—

Measure

Time frame

1. Time taken to achieve BIS value of 50 2. Change in heart rate between the study groups 3. Other side effects of intravenous study drugs (such as myoclonus, pain on injection etc) 4. SAD related parameters (insertion summed score, number of attempts taken, time taken for insertion, additional study drug boluses required) Timepoint: Baseline, At BIS 50, After supraglottic airway placement,1 minute after placement, 2 minutes after placement, 5 minutes after placement

—

Countries

India

Contacts

Public ContactShreya Shah

AIIMS, New Delhi

shreyabs@hotmail.com9892652781

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026