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

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

Tracking Information

• First Submitted Date: November 9, 2020
• First Posted Date: November 13, 2020
• Last Update Posted Date: November 17, 2020
• Actual Study Start Date: July 1, 2009
• Actual Primary Completion Date: December 30, 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (submitted: November 9, 2020)

Heart rate [ Time Frame: 0-120 minutes ]

Heart rate during operation and following operation

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Anesthesia
• Intravenous Anesthetic Toxicity

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 9, 2020): 63
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 31, 2009
• Actual Primary Completion Date: December 30, 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04628559
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Muge Kosucu, Karadeniz Technical University
• Original Responsible Party: Muge Kosucu, Karadeniz Technical University, KaradenizTU
• Current Study Sponsor: Karadeniz Technical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Karadeniz Technical University
• Verification Date: November 2020