Comparison between opioid based with opioid free total intravenous anaesthesia in children undergoing lower abdominal surgeries

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/12/048145
• Lead Sponsor: Maulana Azad Medical College and associated Lok Nayak Hospital

Brief Summary

We are comparing total intravenous anaesthesia using Fentanyl-Propofol vs Dexmedetomidine-Propofol with regards to propofol consumption in paediatric patients undergoing infraumblical surgeries. Here we allocate the child to either group and than give the loading dose of fentanyl or dexmedetomidine for 10 minutes. After that propofol will be given via Target Controlled Infusion (TCI) pump to achieve target plasma concentration of 2mcg/ml and will titrate the infusion to achieve Bispectral Index (BIS) value between 40-60 followed by maintenance dose of fentanyl or dexmedetomidine. Our primary purpose of this study is to assess the propofol requirement at maintenance when anaesthesia is supplemented with fentanyl or dexmedetomidine in children by taking a total sample size of 100, 50 children in each group.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-12
• Study Start: 2022-12-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Children 4-8 years of age belonging to American Society of Anesthesiologists (ASA) grade I and II undergoing elective infraumblical surgery of duration upto two hours under total intravenous anaesthesia.

Exclusion Criteria

• 1.Any known allergies to general anaesthetics.
• 2.Anticipated difficult airway.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of propofol(mg/kg/hr) required for maintenance of anaesthesia in both the groups.	Intraoperatively

Secondary Outcome Measures

Name	Time	Method
Dose of propofol (mg/kg) required for induction of anaesthesia in both the groups.	Intraoperatively
Hemodynamic response to I-Gel insertion.	Intraoperatively
Intraoperative hemodynamic parameters ,respiratory rate and saturation	Intraoperatively
Recovery time (to achieve Modified Aldrete score of 9 and more)	Intraoperatively
Incidence of emergence delirium as assessed by Watcha scale	5 minutes of removal of supraglottic device
Post operative pain assessed by FLACC score	10 minutes after recovery from anaesthesia
Post operative complications ,if any	Post operative period

Trial Locations

Locations (1)

Lok Nayak Hospital; 🇮🇳 Delhi, DELHI, India

Lok Nayak Hospital

🇮🇳Delhi, DELHI, India

Anjali

Principal investigator

8054307370

dr.anjali9191@gmail.com