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

Ketamine

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.

Intervention / Treatment

  • ketamine, propofol (DRUG)
    anesthesia with ketofol in pediatric surgery
  • ketamine, propofol, lidocaine (DRUG)
    anesthesia with ketofol plus lidocaine in pediatric surgery

Condition or Disease

  • Surgical Procedure, Unspecified

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 1 Year to 12 Years
    Enrollment: 200 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    SINGLE:
    • Investigator

    Clinical Trial Dates

    Start date: Jun 20, 2020 ACTUAL
    Primary Completion: Nov 20, 2020 ACTUAL
    Completion Date: Dec 18, 2020 ACTUAL
    Study First Posted: Jul 13, 2020 ACTUAL
    Results First Posted: Feb 04, 2021 ACTUAL
    Last Updated: Jan 15, 2021

    Sponsors / Collaborators

    Lead Sponsor: University Hospital of Split
    Responsible Party: N/A

    Location

    Split, Dalmatia, Croatia

    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.

    Participant Groups

    • ketamine, propofol

    • ketamine, propofol, lidocaine

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * surgical procedures max 60 min ASA I and II

    Exclusion Criteria:

    * ASA \> II surgical procedures longer than 60 min

    Primary Outcomes
    • 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 Outcomes
    • Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption up to 60 minutes

    More Details

    NCT Number: NCT04467424
    Acronym: Lidoketofol
    Other IDs: Ketofol-Lidocaine
    Study URL: https://clinicaltrials.gov/study/NCT04467424
    Last updated: Sep 29, 2023