Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery

Phase 2

Completed

• Conditions: Surgical Procedure, Unspecified
• Interventions: Drug: ketamine, propofol; Drug: ketamine, propofol, lidocaine

• Registration Number: NCT04467424
• Lead Sponsor: University Hospital of Split

Brief Summary

Two hundred children aged 1-12 years undergoing short surgery will be randomized into two groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used. Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU) will be recorded.

Detailed Description

Aim of the research: In this study investigators want to examine the effectiveness of the use of ketofol and a mixture of ketofol and lidocaine on the total consumption of opioids and on the postoperative recovery of pediatric patients. Investigators will evaluate the safety, efficacy, and outcomes of the anesthesia procedure with respect to the administration of different anesthetics, specific pharmakocinetic profiles and compare the length of recovery between patients in two groups.

Including criteria: children aged 1 to 12 years who underwent short surgery (up to 60 min).

Primary and secondary outcome measures: The primary outcome of this study will be extubation time and the secondary outcome will be time spend in PACU.

Description of the study: Each subject included in the study will be given general anesthesia with ketofol or ketofol and lidocaine, with the addition of fentanyl. After 20 s the LMA will be placed. Maintenance of anesthesia will be performed using an air / oxygen mixture (50% / 50%) and an infusion of ketofol or ketofol and lidocaine. Ketofol will be prepare in a ratio of 1: 4 for induction and 1: 7 for maintenance. The same mixtures of ketofol will be added 1 ml of 2% lidocaine for the second group of patients. After extubation, patients will be transferred to the PACU.

Study Timeline

• Study Start: 2020-06-20
• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Results First Submitted: 2020-11-11
• Primary Completion: 2020-11-20
• Study Completion: 2020-12-18
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Results First Posted: 2021-02-04
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• surgical procedures max 60 min ASA I and II

Exclusion Criteria

• ASA > II surgical procedures longer than 60 min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pediatric anesthesia with ketofol	ketamine, propofol	ketamine, propofol
Pediatric anesthesia with ketofol plus lidocaine	ketamine, propofol, lidocaine	ketamine, propofol, lidocaine

Primary Outcome Measures

Name	Time	Method
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children	up to 600 seconds
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU	up to 40 minutes

Secondary Outcome Measures

Name	Time	Method
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption	up to 60 minutes

Trial Locations

Locations (1)

University Hospital of Split; 🇭🇷 Split, Croatia