Skip to main content
OpenTrials
Completed

NCT Number: NCT04467424

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Procedure, Unspecified

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Split

Split, 21000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgical procedures max 60 min ASA I and II

Exclusion criteria

  • ASA > II surgical procedures longer than 60 min

Treatment and study plan

ketamine, propofol

Drug

anesthesia with ketofol in pediatric surgery

ketamine, propofol, lidocaine

Drug

anesthesia with ketofol plus lidocaine in pediatric surgery

Primary outcomes

  1. Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children

    Time frame: up to 600 seconds

  2. Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU

    Time frame: up to 40 minutes

Secondary outcomes

  1. Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption

    Time frame: up to 60 minutes

Sponsors and collaborators

Lead sponsor

University Hospital of Split

Other

Registry information

Official study title

TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery

Acronym: Lidoketofol

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2020
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.