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

Not Applicable

Completed

• Conditions: Anesthesia; Intravenous Anesthetic Toxicity
• Interventions: Drug: Saline; Drug: Dexmedetomidine; Drug: Ketamine

• Registration Number: NCT04628559
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-07-01
• Primary Completion: 2009-12-30
• Study Completion: 2009-12-31
• Status Verified: 2020-11
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-13
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Patients recieving Saline.
Dexmedetomine	Dexmedetomidine	Patients recieving Dexmedetomidine.
Ketamine	Ketamine	Patients recieving Ketamine.

Primary Outcome Measures

Name	Time	Method
Response to verbal stimulus time	0-120 minutes following finishing operation	Verbal response received when the patient was spoken to
Intraoperative additional fentanyl requirement	0-120 minutes following initiating operation	Intraoperative additional fentanyl requirement for pain relief and

Secondary Outcome Measures

Name	Time	Method
Heart rate	0-120 minutes	Heart rate during operation and following operation

Trial Locations

Locations (1)

Medical School of Karadeniz Technical University, Department of Anesthesiology; 🇹🇷 Trabzon, Turkey