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

Karadeniz Technical University

Status: Completed

Conditions: Intravenous Anesthetic Toxicity; Anesthesia

Treatments: Drug: Saline; Drug: Dexmedetomidine; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04628559

2009/137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 3 patient groups, including a placebo group

Dexmedetomine

Active Comparator group

Description:

Patients recieving Dexmedetomidine.

Treatment:

Drug: Dexmedetomidine

Ketamine

Active Comparator group

Description:

Patients recieving Ketamine.

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

Patients recieving Saline.

Treatment:

Drug: Saline