NCT07276633

Brief Summary

This study investigates whether administering a low, sub-anesthetic dose of propofol before extubation can reduce emergence agitation and improve perioperative comfort in patients undergoing rhinoplasty. Emergence agitation refers to restlessness and confusion during early recovery from anesthesia, which may affect patient safety and surgical conditions. The study evaluates agitation levels, recovery characteristics, and patient-reported comfort following propofol administration compared with standard care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

November 16, 2025

Last Update Submit

December 10, 2025

Conditions

Keywords

PropofolPostoperative RecoveryPatient SatisfactionEmergence AgitationRhinoplastyGeneral Anesthesia RecoverySub-Anesthetic Dose

Outcome Measures

Primary Outcomes (1)

  • Changing Preoperative Anxiety Score (STAI)

    Comparison of the State-Trait Anxiety Inventory (STAI) state anxiety score measured in the preoperative waiting room (T1) with the STAI score 15 minutes after the palming technique (T2). The difference between the two time points is analyzed to assess the anxiety-reducing effect of the intervention.

    15 minutes (T1-T2)

Secondary Outcomes (2)

  • Hemodynamic Parameter Changes

    15 minutes (T1-T2)

  • Hemodynamic Parameter Changes

    15 minutes (T1-T2)

Study Arms (2)

Propofol Group

ACTIVE COMPARATOR

Sub-anesthetic dose of propofol (0.5 mg/kg) administered 10 minutes before extubation.

Other: Normal Saline (Placebo)

Control Group

SHAM COMPARATOR

Normal saline administered 10 minutes before extubation.

Drug: Propofol (Sub-Anesthetic Dose)

Interventions

Participants receive 0.5 mg/kg intravenous propofol as a single bolus 10 minutes before extubation.

Also known as: Normal saline administered pre-extubation
Control Group

Participants receive an equivalent volume of normal saline 10 minutes before extubation.

Propofol Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-65 years
  • Patients scheduled for rhinoplasty surgery
  • ASA physical status I-II
  • No respiratory tract infection
  • Provided written informed consent

You may not qualify if:

  • Refusal to participate
  • Presence of any respiratory tract infection
  • Younger than 18 or older than 65
  • ASA III-IV
  • Known allergy to study medications
  • Predicted difficult intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University, Dursun Odabas Medical Center

Van, 65080, Turkey (Türkiye)

Location

Related Publications (1)

  • Kanaya A, Kuratani N, Satoh D, Kurosawa S. Lower incidence of emergence agitation in children after propofol anesthesia compared with sevoflurane: a meta-analysis of randomized controlled trials. J Anesth. 2014 Feb;28(1):4-11. doi: 10.1007/s00540-013-1656-y. Epub 2013 Jun 26.

    PMID: 23800983BACKGROUND

MeSH Terms

Conditions

Emergence DeliriumPatient Satisfaction

Interventions

PropofolSaline Solution

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Nureddin Yuzkat, Associate professor

    Yuzuncu Yil University Dursun Odabas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 11, 2025

Study Start

June 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

December 11, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available because data sharing was not included in the informed consent and sharing such data could compromise patient confidentiality.

Locations