Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations

Ketamine

Brief Summary

This randomized double-blind study aimed to compare the effects of dexmedetomidine and ketamine on hemodynamic parameters, recovery criteria, and opioid consumption and advers effects in septorhinoplasty operations. Totally 63 patients were included. The groups were compared in terms of hemodynamic values, recovery times, postoperative agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia requirements at postoperative 24h.

Intervention / Treatment

1. First arm received dexmedetomidine 2. Second arm received ketamine 3. Third arm received saline solution.
  • Dexmedetomidine (DRUG)
    dexmedetomidine was administered as a gradual bolus of 1 µg/kg/10ml 10 min before induction of anesthesia and then as an infusion of 0.4 µg/kg per min (30 ml/h). In Group K, ketamine was administered as a 0.4 mg/kg/10ml IV bolus 10 min before induction of anesthesia and in the form of 10 µg/kg per min infusion after induction (30 ml/h).
  • Ketamine (DRUG)
    In Group K, ketamine was administered as a 0.4 mg/kg/10ml IV bolus 10 min before induction of anesthesia and in the form of 10 µg/kg per min infusion after induction (30 ml/h).
  • Saline (DRUG)
    Group S was given a bolus of saline solution in 10 ml volume 10 min before induction of anesthesia, followed by 30 mL/h serum saline infusion.

Condition or Disease

  • Anesthesia
  • Intravenous Anesthetic Toxicity

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 63 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    The surgeon and observers were all blinded to the patients until the end of the study.

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jul 01, 2009 ACTUAL
    Primary Completion: Dec 30, 2009 ACTUAL
    Completion Date: Dec 31, 2009 ACTUAL
    Study First Posted: Nov 13, 2020 ACTUAL
    Last Updated: Nov 13, 2020

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    A total of 63 patients 18-55 years undergoing septorhinoplasty, who were graded as American Society of Anesthesiologists physical status were randomly allocated into three groups, receiving dexmedetomidine (n=21, Group D), ketamine (n=21, Group K) and saline solution (n=21, Group S). Anesthesia was induced with propofol, cisatracurium and fentanyl. Maintenance anesthesia was done with 2-2.5% sevoflurane mixture, 50-60% oxygen and N2O. The groups were compared in terms of hemodynamic values, recovery times, postoperative agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia requirements at postoperative 24h.

    Participant Groups

    • Patients recieving Dexmedetomidine.

    • Patients recieving Ketamine.

    • Patients recieving Saline.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patient graded as American Society of Anesthesiologist (ASA) physical status, I or II
    * Patient subjected to septorhineoplasty operation

    Exclusion Criteria:

    * Patient having morbid obesity,
    * Patient having yypertension,
    * Patient having Asthma,
    * Patient having neuropsychiatric disease,
    * Patient allergy to the study drugs.

    Primary Outcomes

    • Verbal response received when the patient was spoken to

    • Intraoperative additional fentanyl requirement for pain relief and

    Secondary Outcomes

    • Heart rate during operation and following operation

    More Details

    NCT Number: NCT04628559
    Other IDs: 2009/137
    Study URL: https://clinicaltrials.gov/study/NCT04628559
    Last updated: Sep 29, 2023