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History of Changes for Study: NCT04628559
Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Latest version (submitted November 13, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 9, 2020 None (earliest Version on record)
2 November 13, 2020 Arms and Interventions, Conditions, Sponsor/Collaborators and Study Status
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Study NCT04628559
Submitted Date:  November 9, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2009/137
Brief Title: Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Official Title: Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Completed
Study Start: July 1, 2009
Primary Completion: December 30, 2009 [Actual]
Study Completion: December 31, 2009 [Actual]
First Submitted: November 9, 2020
First Submitted that
Met QC Criteria:
November 9, 2020
First Posted: November 13, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 9, 2020
Last Update Posted: November 13, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Karadeniz Technical University
Responsible Party: Principal Investigator
Investigator: Muge Kosucu
Official Title: KaradenizTU
Affiliation: Karadeniz Technical University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.

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.
Open or close this module Conditions
Conditions: Anesthesia, Intravenous
Keywords: Dexmedetomidine, ketamine, perioperative effects
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
  1. First arm received dexmedetomidine
  2. Second arm received ketamine
  3. Third arm received saline solution.
Number of Arms: 3
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 63 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Group D
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: Group K
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: Group S
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Study Officials: Muge Muge, Assoc Prof
Study Chair
Medical School of Karadeniz Technical University, Department of Anesthesiology
Locations: Turkey
Medical School of Karadeniz Technical University, Department of Anesthesiology
Trabzon, Turkey
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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