Use of Subanesthetic Dose Propofol Before Extubation

NCT ID: NCT07276633

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-10-01

Brief Summary

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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

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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

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Emergence Agitation Rhinoplasty Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Propofol Group

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

Group Type ACTIVE_COMPARATOR

Normal Saline (Placebo)

Intervention Type OTHER

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

Control Group

Normal saline administered 10 minutes before extubation.

Group Type SHAM_COMPARATOR

Propofol (Sub-Anesthetic Dose)

Intervention Type DRUG

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

Interventions

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Propofol (Sub-Anesthetic Dose)

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

Intervention Type DRUG

Normal Saline (Placebo)

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

Intervention Type OTHER

Other Intervention Names

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Normal saline administered pre-extubation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yil University

OTHER

Sponsor Role lead

Responsible Party

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Nureddin YUZKAT

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nureddin Yuzkat, Associate professor

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yil University Dursun Odabas Medical Center

Locations

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Yuzuncu Yil University, Dursun Odabas Medical Center

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23800983 (View on PubMed)

Other Identifiers

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Subanesthetic Dose of Propofol

Identifier Type: -

Identifier Source: org_study_id

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