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

NCT04628559 | Completed

• 1 other identifier: 2009/137
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Intravenous Anesthetic Toxicity

Keywords

Dexmedetomidine; Ketamine; Perioperative effects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Heart rate

  0-120 minutes

Study Arms (3)

Dexmedetomine

ACTIVE COMPARATOR

Patients recieving Dexmedetomidine.

Drug: Dexmedetomidine

Ketamine

ACTIVE COMPARATOR

Patients recieving Ketamine.

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Patients recieving Saline.

Drug: Saline

Interventions

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).

Also known as: Group D

Dexmedetomine

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).

Also known as: Group K

Ketamine

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.

Also known as: Group S

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient graded as American Society of Anesthesiologist (ASA) physical status, I or II
• Patient subjected to septorhineoplasty operation

You may not qualify if:

• Patient having morbid obesity,
• Patient having yypertension,
• Patient having Asthma,
• Patient having neuropsychiatric disease,
• Patient allergy to the study drugs.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Medical School of Karadeniz Technical University, Department of Anesthesiology

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dexmedetomidine; Ketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Muge Muge, Assoc Prof

  Medical School of Karadeniz Technical University, Department of Anesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The surgeon and observers were all blinded to the patients until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associated Professor

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

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 13, 2020
• Study Start: July 1, 2009
• Primary Completion: December 30, 2009
• Study Completion: December 31, 2009
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)