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Clinical Trials/NCT07276633
NCT07276633
Completed
Not Applicable

Effect of Subanesthetic Dose Propofol Use Before Extubation on Recovery From Anesthesia, Agitation on Recovery, and Patient Satisfaction

Yuzuncu Yil University1 site in 1 country80 target enrollmentStarted: June 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Yuzuncu Yil University
Enrollment
80
Locations
1
Primary Endpoint
Changing Preoperative Anxiety Score (STAI)

Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Propofol Group

Active Comparator

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

Intervention: Normal Saline (Placebo) (Other)

Control Group

Sham Comparator

Normal saline administered 10 minutes before extubation.

Intervention: Propofol (Sub-Anesthetic Dose) (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Hemodynamic Parameter Changes(15 minutes (T1-T2))

Investigators

Sponsor
Yuzuncu Yil University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nureddin YUZKAT

Associate professor

Yuzuncu Yil University

Study Sites (1)

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