Emergence AgitationNCT07276633
Use of Subanesthetic Dose Propofol Before Extubation
A study testing Propofol (Sub-Anesthetic Dose) in people with Emergence Agitation and Rhinoplasty, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emergence Agitation, Rhinoplasty, Patient Satisfaction
- What is being tested?
- Propofol (Sub-Anesthetic Dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65 years
- Patients scheduled for rhinoplasty surgery
- ASA physical status I-II
- No respiratory tract infection
- Provided written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University, Dursun Odabas Medical Center
Van, 65080
About this study
Official title: 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.
Read the 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.
- Conditions
- Emergence Agitation, Rhinoplasty, Patient Satisfaction
- Being tested
- Propofol (Sub-Anesthetic Dose), Normal Saline (Placebo)
- Keywords
- Propofol, Postoperative Recovery, Patient Satisfaction, Emergence Agitation, Rhinoplasty, General Anesthesia Recovery, Sub-Anesthetic Dose
- Medical subject headings
- Emergence Delirium, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol (Sub-Anesthetic Dose)Drug
Also called Normal saline administered pre-extubation
Participants receive 0.5 mg/kg intravenous propofol as a single bolus 10 minutes before extubation.
Normal Saline (Placebo)Other
Participants receive an equivalent volume of normal saline 10 minutes before extubation.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Active comparator | Sub-anesthetic dose of propofol (0.5 mg/kg) administered 10 minutes before extubation. Receives: Other: Normal Saline (Placebo) |
| Control Group | Sham comparator | Normal saline administered 10 minutes before extubation. Receives: Drug: Propofol (Sub-Anesthetic Dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes (T1-T2)
Secondary outcomes (2)
Hemodynamic Parameter Changes
Changes in heart rate (HR) values between the T1 and T2 time points. The effect of the palming technique on hemodynamic stability is evaluated.
Measured: 15 minutes (T1-T2)
Hemodynamic Parameter Changes
Changes in mean blood pressure values between the T1 and T2 time points. The effect of the palming technique on hemodynamic stability is evaluated.
Measured: 15 minutes (T1-T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jun 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nureddin YUZKAT, Yuzuncu Yil University
- Investigators
- Nureddin Yuzkat, Associate professor, Principal investigator, Yuzuncu Yil University Dursun Odabas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276633
- Sponsor's protocol ID
- Subanesthetic Dose of Propofol
- Status last verified
- May 2024
- First submitted
- 16 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 23800983Izmir E, Yuzkat N, Kiyat H, Tekeli AE, Gunes HY, Kurt N, Keskin ME. Effect of a subanesthetic dose of propofol on emergence agitation in adults undergoing rhinoplasty: A prospective randomized controlled trial. Medicine (Baltimore). 2026 Jul 10;105(28):e49693. doi: 10.1097/MD.0000000000049693.
PubMed 42432924
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Subanesthetic Dose Propofol Use Before Extubation on Recovery From Anesthesia, Agitation on Recovery, and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07276633
- Acronym / sponsor ID
- Subanesthetic Dose of Propofol
- Conditions
- Emergence Agitation, Rhinoplasty, Patient Satisfaction
- Keywords
- Propofol, Postoperative Recovery, Patient Satisfaction, Emergence Agitation, Rhinoplasty, General Anesthesia Recovery, Sub-Anesthetic Dose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Active comparator | Other: Normal Saline (Placebo)Sub-anesthetic dose of propofol (0.5 mg/kg) administered 10 minutes before extubation. |
| Control Group | Sham comparator | Drug: Propofol (Sub-Anesthetic Dose)Normal saline administered 10 minutes before extubation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-65 years
- Patients scheduled for rhinoplasty surgery
- ASA physical status I-II
- No respiratory tract infection
- Provided written informed consent
Key exclusion criteria (6 listed)
- Refusal to participate
- Presence of any respiratory tract infection
- Younger than 18 or older than 65
- ASA III-IV
- Known allergy to study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol (Sub-Anesthetic Dose)Also: Normal saline administered pre-extubationParticipants receive 0.5 mg/kg intravenous propofol as a single bolus 10 minutes before extubation. | Drug | Control Group |
| Normal Saline (Placebo)Participants receive an equivalent volume of normal saline 10 minutes before extubation. | Other | Propofol Group |
Primary outcome
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.
2 secondary outcomes
Hemodynamic Parameter Changes
Time frame: 15 minutes (T1-T2)
Hemodynamic Parameter Changes
Time frame: 15 minutes (T1-T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Background: PubMed 23800983Kanaya 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.
- Derived from this study: PubMed 42432924Izmir E, Yuzkat N, Kiyat H, Tekeli AE, Gunes HY, Kurt N, Keskin ME. Effect of a subanesthetic dose of propofol on emergence agitation in adults undergoing rhinoplasty: A prospective randomized controlled trial. Medicine (Baltimore). 2026 Jul 10;105(28):e49693. doi: 10.1097/MD.0000000000049693.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nureddin Yuzkat, Associate professor principal investigator
Yuzuncu Yil University Dursun Odabas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol (Sub-Anesthetic Dose) in people with Emergence Agitation and Rhinoplasty, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing Preoperative Anxiety Score (STAI) (time frame: 15 minutes (T1-T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07276633, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.