Comparison of Ketamine-propofol Combinations

Ketamine

Brief Summary

ASA I-II 3-12 years old children participated to this study. All Participants will divide into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of ketamine-propofol mixture with %67 of Mcfarlan dose regiment. In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol mixture with %80 of Mcfarlan dose regiment. In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90 of Mcfarlan dose regiment. After than surgical operation recovery time, PAED scores, FLACC scores, Staying time in PACU will be recorded. These data will be evaluated with statistically.

Intervention / Treatment

  • Ketamine-propofol mixture (DRUG)
    Ratio of Ketamine-propofol mixture will be compare for every groups.

Condition or Disease

  • Agitation
  • Postoperative Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 12 Years
    Enrollment: 75 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Jul 01, 2016
    Primary Completion: Feb 01, 2017 ACTUAL
    Completion Date: Feb 01, 2017 ACTUAL
    Study First Posted: Jul 29, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 19, 2017

    Sponsors / Collaborators

    Lead Sponsor: Cukurova University
    Responsible Party: N/A

    Location

    Sarıçam, Turkey
    Adana, Sarıçam, Turkey

    ASA I-II, 3-12 years old children who will operate due to tonsillectomy and adenoidectomy. will be participated in to this study. All Participants will divide into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of ketamine-propofol mixture with %67 of Mcfarlan dose regiment.

    In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol mixture with %80 of Mcfarlan dose regiment.

    In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90 of Mcfarlan dose regiment.

    McFarlan dose regiments include 15 mg/kg/h infusion during 15 minutes, 13 mg/kg/h infusion during second 15 minutes, 11 mg/kg/h infusion from 30 to 60 minutes, 10 mg/kg/h from 1 to 2 h.

    Anaesthesia dept will be detect with BIS monitoring during operation. After than surgical operation recovery time, PAED scores, FLACC scores, staying time in PACU and extubation time will be record. At the end of the study, these data will be evaluated with statistically.

    Participant Groups

    • Ketamine-propofol mixture will be compare for every groups.

    • Ketamine-propofol mixture will be compare for every groups.

    • Ketamine-propofol mixture will be compare for every groups

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * ASA I-II children
    * Children who will be performed to adenoidectomy and tonsillectomy surgical operations

    Exclusion Criteria:

    * ASA III-IV children
    * Patients over the age of 13

    Primary Outcomes

    • All patients will be evaluate with PAED scores at PACU during first 1 hour

    Secondary Outcomes

    • All Patients will monitored with BIS monitoring during operation.

    • At the end of the surgery, time from injection of reversal to extubation

    • All patients will be evaluate with FLACC scores at PACU during first 1 hour

    More Details

    NCT Number: NCT02848963
    Other IDs: Ketamine-Propofol
    Study URL: https://clinicaltrials.gov/study/NCT02848963
    Last updated: Sep 29, 2023