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

Sponsor
Karadeniz Technical University (Other)
Overall Status
Completed
CT.gov ID
NCT04628559
Collaborator
(none)
63
Enrollment
1
Location
3
Arms
6
Actual Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
First arm received dexmedetomidine Second arm received ketamine Third arm received saline solution.First arm received dexmedetomidine Second arm received ketamine Third arm received saline solution.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
The surgeon and observers were all blinded to the patients until the end of the study.
Primary Purpose:
Treatment
Official Title:
Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Actual Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Dec 30, 2009
Actual Study Completion Date :
Dec 31, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dexmedetomine

Patients recieving Dexmedetomidine.

Drug: Dexmedetomidine
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).
Other Names:
  • Group D

    		•
    Active Comparator: Ketamine

    Patients recieving Ketamine.

    Drug: Ketamine
    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).
    Other Names:
  • Group K

    		•
    Placebo Comparator: Placebo

    Patients recieving Saline.

    Drug: Saline
    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.
    Other Names:
  • Group S

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response to verbal stimulus time [0-120 minutes following finishing operation]

      Verbal response received when the patient was spoken to

    2. Intraoperative additional fentanyl requirement [0-120 minutes following initiating operation]

      Intraoperative additional fentanyl requirement for pain relief and

    Secondary Outcome Measures

    1. Heart rate [0-120 minutes]

      Heart rate during operation and following operation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical School of Karadeniz Technical University, Department of Anesthesiology Trabzon Turkey

    Sponsors and Collaborators

    • Karadeniz Technical University

    Investigators

    • Study Chair: Muge Muge, Assoc Prof, Medical School of Karadeniz Technical University, Department of Anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Muge Kosucu, Clinical Associated Professor, Karadeniz Technical University
    ClinicalTrials.gov Identifier:
    NCT04628559
    Other Study ID Numbers:
    • 2009/137
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Muge Kosucu, Clinical Associated Professor, Karadeniz Technical University
    Dexmedetomidine
    Ketamine
    Perioperative effects
    Additional relevant MeSH terms:
    Dexmedetomidine
    Ketamine

    Study Results

    No Results Posted as of Nov 17, 2020