Prevention of Emergence Agitation in Rhinoplasty With Subanesthetic Propofol and Single-Dose Dexmedetomidine: A Prospective Double-Blind Clinical Study

NCT07144007 | Recruiting

• 1 other identifier: 2025/04-07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To compare of prevention of emergence agitation in rhinoplasty with subanesthetic propofol and single dose dexmedetomidine

Conditions

Emergence Agitation

Keywords

emergence agitaion; Propofol; Dexmedetomidine; Rhinoplasty

Outcome Measures

Primary Outcomes (1)

• Agitation status

  The effect on prevention of emergence agitation of propofol and dexmedetomidine will be evaluated by an anaesthetist with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation

  1. minute after extubation

Secondary Outcomes (3)

• Heart rate

  perioperatively defined times

• Blood Pressure

  perioperatively defined times

• oxygen saturation

  perioperatively defined times

Study Arms (2)

Dexmedetomidine (Group-D)

ACTIVE COMPARATOR

Group-D: Dexmedetomidine group (n:40). In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing.

Drug: Dexmedetomidine

Propofol (Group-P)

EXPERIMENTAL

Group-P: Propofol group (n:40). In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing.

Drug: Propofol

Interventions

Dexmedetomidine DRUG

In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing

Dexmedetomidine (Group-D)

Propofol DRUG

In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing

Propofol (Group-P)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for rhinoplasty
• Between 18-65 years
• ASA I-II group

You may not qualify if:

• Those who are outside the age range of 18-65
• Those who are ASA III and above
• Those with renal,hepatic, cardiac and respiratory diseases
• Those with a known allergy to the medication to be used
• Those who underwent urinary catheterization

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl University

Van, Tuşba, 65100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Makkar JK, Bhatia N, Bala I, Dwivedi D, Singh PM. A comparison of single dose dexmedetomidine with propofol for the prevention of emergence delirium after desflurane anaesthesia in children. Anaesthesia. 2016 Jan;71(1):50-7. doi: 10.1111/anae.13230. Epub 2015 Oct 7.

  PMID: 26444149 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Şükran Sevimli, Assoc. Prof.

  Yuzuncu Yil University

  STUDY DIRECTOR

Central Study Contacts

Mehmet Emin Keskin, assistant professor

CONTACT

+90 553 071 66 55; emin6559@hotmail.com

Bedrettin Bingöl, MD

CONTACT

+90 507 211 92 28; bedrettinbingolbb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 80 patients scheduled for rhinoplasty will be randomly assigned to two groups. After nasal packing placement, one group will receive intraoperative 0.5 mg/kg propofol, while the other group will receive 10-minute infusion of 0.5 mcg/kg dexmedetomidine.

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: April 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year
• Access Criteria: The access can be provided via the e-mail addresses below emin6559@hotmail.com

Locations

TU (1)