- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07276633
Use of Subanesthetic Dose Propofol Before Extubation
December 10, 2025 updated by: Nureddin YUZKAT, Yuzuncu Yil University
Effect of Subanesthetic Dose Propofol Use Before Extubation on Recovery From Anesthesia, Agitation on Recovery, and Patient Satisfaction
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate whether administering a sub-anesthetic dose of propofol before extubation can reduce emergence agitation, enhance recovery characteristics, and improve patient comfort in adults undergoing rhinoplasty surgery.
Emergence agitation is a common phenomenon during early recovery from general anesthesia and can involve restlessness, disorientation, and involuntary movements, potentially affecting patient safety and surgical outcomes.
The study uses a randomized controlled design to compare peri-extubation responses between patients receiving low-dose propofol and those receiving standard care.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Van, Turkey (Türkiye), 65080
- Yuzuncu Yil University, Dursun Odabas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Ages 18-65 years
- Patients scheduled for rhinoplasty surgery
- ASA physical status I-II
- No respiratory tract infection
- Provided written informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Propofol Group
Sub-anesthetic dose of propofol (0.5 mg/kg) administered 10 minutes before extubation.
|
Participants receive an equivalent volume of normal saline 10 minutes before extubation.
|
|
Sham Comparator: Control Group
Normal saline administered 10 minutes before extubation.
|
Participants receive 0.5 mg/kg intravenous propofol as a single bolus 10 minutes before extubation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changing Preoperative Anxiety Score (STAI)
Time Frame: 15 minutes (T1-T2)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodynamic Parameter Changes
Time Frame: 15 minutes (T1-T2)
|
Changes in heart rate (HR) values between the T1 and T2 time points.
The effect of the palming technique on hemodynamic stability is evaluated.
|
15 minutes (T1-T2)
|
|
Hemodynamic Parameter Changes
Time Frame: 15 minutes (T1-T2)
|
Changes in mean blood pressure values between the T1 and T2 time points.
The effect of the palming technique on hemodynamic stability is evaluated.
|
15 minutes (T1-T2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nureddin Yuzkat, Associate professor, Yuzuncu Yil University Dursun Odabas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
October 1, 2024
Study Registration Dates
First Submitted
November 16, 2025
First Submitted That Met QC Criteria
December 10, 2025
First Posted (Actual)
December 11, 2025
Study Record Updates
Last Update Posted (Actual)
December 11, 2025
Last Update Submitted That Met QC Criteria
December 10, 2025
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Treatment Adherence and Compliance
- Health Behavior
- Emergence Delirium
- Patient Satisfaction
- Organic Chemicals
- Pharmaceutical Preparations
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Phenols
- Benzene Derivatives
- Crystalloid Solutions
- Isotonic Solutions
- Solutions
- Propofol
- Saline Solution
Other Study ID Numbers
- Subanesthetic Dose of Propofol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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