Ketamin Plus Propofol for Anesthesia Induction

Ketamine

Brief Summary

ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

Intervention / Treatment

Randomised, controlled
  • Ketamine (DRUG)
    Different mixture of ketamin-propofol will apply for anesthesia induction.

Condition or Disease

  • Postoperative Recovery

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 12 Years
    Enrollment: 112 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Feb 15, 2021 ACTUAL
    Primary Completion: Dec 15, 2022 ACTUAL
    Completion Date: Dec 15, 2022 ACTUAL
    Study First Posted: Feb 18, 2021 ACTUAL
    Last Updated: Apr 18, 2023

    Sponsors / Collaborators

    Lead Sponsor: Cukurova University
    Responsible Party: N/A

    ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery in this randomised controlled study. The participants will divide into the 4 groups with computered random generation. The Different combination of propofol+ketamin mixture will apply at the induction of anesthesia. The groups will assign as group I,II, III and IV. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. Fentanyl 1 microgram per kg and rocuronium 0.6 mg/kg will apply for anesthesia induction to the all participants. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

    Participant Groups

    • Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I to anesthesia induction.

    • propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II to anesthesia induction

    • propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III to anesthesia induction

    • propofol 3 mg/kg will perform for anesthesia induction

    Eligibility Criteria

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

    Inclusion Criteria:

    * ASA I-II patients
    * Underwent adenoidectomy-tonsillectomy surgery
    * Age between 3-12

    Exclusion Criteria:

    * ASA III-IV patients
    * Age; under 3 years old
    * Age; above 12 years old.

    Primary Outcomes

    • Watcha scores will record till the patient discharge from the PACU.

    Secondary Outcomes

    • The participants will observe in PACU till the Aldrete score will achieve 15. This duration of time will record.

    More Details

    NCT Number: NCT04761159
    Other IDs: Ketamin-propofol
    Study URL: https://clinicaltrials.gov/study/NCT04761159
    Last updated: Sep 29, 2023