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

January 15, 2021 updated by: Ana N Biliškov, MD, University Hospital of Split

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • University Hospital of Split

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • surgical procedures max 60 min ASA I and II

Exclusion Criteria:

  • ASA > II surgical procedures longer than 60 min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pediatric anesthesia with ketofol
ketamine, propofol
Drug: ketamine, propofol
anesthesia with ketofol in pediatric surgery
EXPERIMENTAL: Pediatric anesthesia with ketofol plus lidocaine
ketamine, propofol, lidocaine
Drug: ketamine, propofol, lidocaine
anesthesia with ketofol plus lidocaine in pediatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children
Time Frame: up to 600 seconds
up to 600 seconds
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU
Time Frame: up to 40 minutes
up to 40 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption
Time Frame: up to 60 minutes
up to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Split

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2020

Primary Completion (ACTUAL)

November 20, 2020

Study Completion (ACTUAL)

December 18, 2020

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (ACTUAL)

July 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ketofol-Lidocaine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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