Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
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|ClinicalTrials.gov Identifier: NCT04628559|
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : November 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Intravenous Anesthetic Toxicity||Drug: Dexmedetomidine Drug: Ketamine Drug: Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||The surgeon and observers were all blinded to the patients until the end of the study.|
|Official Title:||Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations|
|Actual Study Start Date :||July 1, 2009|
|Actual Primary Completion Date :||December 30, 2009|
|Actual Study Completion Date :||December 31, 2009|
Active Comparator: Dexmedetomine
Patients recieving 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
Active Comparator: Ketamine
Patients recieving 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
Placebo Comparator: Placebo
Patients recieving 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
- 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
- Heart rate [ Time Frame: 0-120 minutes ]Heart rate during operation and following operation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628559
|Medical School of Karadeniz Technical University, Department of Anesthesiology|
|Study Chair:||Muge Muge, Assoc Prof||Medical School of Karadeniz Technical University, Department of Anesthesiology|