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Completed

NCT Number: NCT04628559

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

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.

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Key information

Conditions

Anesthesia Intravenous Anesthetic Toxicity

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical School of Karadeniz Technical University, Department of Anesthesiology

Trabzon, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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 names: Group D

ketamine

Drug

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 names: Group K

Saline

Drug

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 names: Group S

Primary outcomes

  1. Response to verbal stimulus time

    Time frame: 0-120 minutes following finishing operation

    Verbal response received when the patient was spoken to

  2. Intraoperative additional fentanyl requirement

    Time frame: 0-120 minutes following initiating operation

    Intraoperative additional fentanyl requirement for pain relief and

Secondary outcomes

  1. Heart rate

    Time frame: 0-120 minutes

    Heart rate during operation and following operation

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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