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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04628559
Enrollment
63
Registered
2020-11-13
Start date
2009-07-01
Completion date
2009-12-31
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Intravenous Anesthetic Toxicity

Keywords

Dexmedetomidine, Ketamine, Perioperative effects

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.

Interventions

DRUGDexmedetomidine

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).

DRUGKetamine

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).

DRUGSaline

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.

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

The surgeon and observers were all blinded to the patients until the end of the study.

Intervention model description

1. First arm received dexmedetomidine 2. Second arm received ketamine 3. Third arm received saline solution.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Response to verbal stimulus time0-120 minutes following finishing operationVerbal response received when the patient was spoken to
Intraoperative additional fentanyl requirement0-120 minutes following initiating operationIntraoperative additional fentanyl requirement for pain relief and

Secondary

MeasureTime frameDescription
Heart rate0-120 minutesHeart rate during operation and following operation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026