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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
Anesthesia Intravenous Anesthetic Toxicity Drug: Dexmedetomidine Drug: Ketamine Drug: Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
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
Official Title: Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : December 30, 2009
Actual Study Completion Date : December 31, 2009

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Group S




Primary Outcome Measures :
  1. Response to verbal stimulus time [ Time Frame: 0-120 minutes following finishing operation ]
    Verbal response received when the patient was spoken to

  2. Intraoperative additional fentanyl requirement [ Time Frame: 0-120 minutes following initiating operation ]
    Intraoperative additional fentanyl requirement for pain relief and


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 0-120 minutes ]
    Heart rate during operation and following operation



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628559


Locations
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Turkey
Medical School of Karadeniz Technical University, Department of Anesthesiology
Trabzon, Turkey
Sponsors and Collaborators
Karadeniz Technical University
Investigators
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Study Chair: Muge Muge, Assoc Prof Medical School of Karadeniz Technical University, Department of Anesthesiology
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Responsible Party: Muge Kosucu, Clinical Associated Professor, Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT04628559    
Other Study ID Numbers: 2009/137
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Karadeniz Technical University:
Dexmedetomidine
Ketamine
Perioperative effects
Additional relevant MeSH terms:
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Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents