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

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ClinicalTrials.gov Identifier: NCT04628559
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Muge Kosucu, Karadeniz Technical University

Tracking Information
First Submitted Date  ICMJE November 9, 2020
First Posted Date  ICMJE November 13, 2020
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE July 1, 2009
Actual Primary Completion Date December 30, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
  • Response to verbal stimulus time [ Time Frame: 0-120 minutes following finishing operation ]
    Verbal response received when the patient was spoken to
  • Intraoperative additional fentanyl requirement [ Time Frame: 0-120 minutes following initiating operation ]
    Intraoperative additional fentanyl requirement for pain relief and
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
Heart rate [ Time Frame: 0-120 minutes ]
Heart rate during operation and following operation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Official Title  ICMJE Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. First arm received dexmedetomidine
  2. Second arm received ketamine
  3. 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
Condition  ICMJE
  • Anesthesia
  • Intravenous Anesthetic Toxicity
Intervention  ICMJE
  • 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 Name: Group D
  • 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 Name: Group K
  • 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 Name: Group S
Study Arms  ICMJE
  • Active Comparator: Dexmedetomine
    Patients recieving Dexmedetomidine.
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Ketamine
    Patients recieving Ketamine.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Patients recieving Saline.
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2020)
63
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2009
Actual Primary Completion Date December 30, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04628559
Other Study ID Numbers  ICMJE 2009/137
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Muge Kosucu, Karadeniz Technical University
Study Sponsor  ICMJE Karadeniz Technical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Muge Muge, Assoc Prof Medical School of Karadeniz Technical University, Department of Anesthesiology
PRS Account Karadeniz Technical University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP