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

U

University Hospital of Split

Status and phase

Completed
Phase 2

Conditions

Surgical Procedure, Unspecified

Treatments

Drug: ketamine, propofol
Drug: ketamine, propofol, lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT04467424
Ketofol-Lidocaine

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

1 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • surgical procedures max 60 min ASA I and II

Exclusion criteria

  • ASA > II surgical procedures longer than 60 min

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Pediatric anesthesia with ketofol
Experimental group
Description:
ketamine, propofol
Treatment:
Drug: ketamine, propofol
Pediatric anesthesia with ketofol plus lidocaine
Experimental group
Description:
ketamine, propofol, lidocaine
Treatment:
Drug: ketamine, propofol, lidocaine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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