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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Intravenous Anesthetic Toxicity

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Ketamine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First arm received dexmedetomidine Second arm received ketamine Third arm received saline solution.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomine<br>Patients recieving Dexmedetomidine. | Drug: Dexmedetomidine<br>* 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).<br>* Other names: Group D;|
| Active Comparator: Ketamine<br>Patients recieving Ketamine. | Drug: Ketamine<br>* 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).<br>* Other names: Group K;|
| Placebo Comparator: Placebo<br>Patients recieving Saline. | Drug: Saline<br>* 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.<br>* Other names: Group S;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate during operation and following operation | 0-120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Ketamine, Perioperative effects