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

NCT ID: NCT04467424

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-20
• Study Completion Date: 2020-12-18

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.

Conditions

Surgical Procedure, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Pediatric anesthesia with ketofol

ketamine, propofol

Group Type: EXPERIMENTAL

ketamine, propofol

Intervention Type: DRUG

anesthesia with ketofol in pediatric surgery

Pediatric anesthesia with ketofol plus lidocaine

ketamine, propofol, lidocaine

Group Type: EXPERIMENTAL

ketamine, propofol, lidocaine

Intervention Type: DRUG

anesthesia with ketofol plus lidocaine in pediatric surgery

Interventions

ketamine, propofol

anesthesia with ketofol in pediatric surgery

Intervention Type: DRUG

ketamine, propofol, lidocaine

anesthesia with ketofol plus lidocaine in pediatric surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• surgical procedures max 60 min ASA I and II

Exclusion Criteria

• ASA > II surgical procedures longer than 60 min

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Split

OTHER

Sponsor Role: lead

Responsible Party

Ana N Biliškov, MD

Pediatric anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Split

Split, , Croatia

Countries

Croatia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Ketofol-Lidocaine

Identifier Type: -

Identifier Source: org_study_id