NCT04628559

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Karadeniz Technical University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia
• Intravenous Anesthetic Toxicity

Interventions

Type	Name	Description
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).
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).
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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-12-30
• Completion: 2009-12-31
• First posted: 2020-11-13
• Last updated: 2020-11-17

Locations

1 site across 1 country: Turkey (Türkiye)