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Clinical Trials/NCT07416773
NCT07416773
Completed
Not Applicable

Evaluation of the Relationship Between Anesthesia Type and Postoperative Sleep Quality in Patients Undergoing Septoplasty: A Prospective Observational Study

Sevim Şenol Karataş2 sites in 1 country72 target enrollmentStarted: November 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Sevim Şenol Karataş
Enrollment
72
Locations
2
Primary Endpoint
Richards-Campbell Sleep Questionnaire (RCSQ) Total Score

Overview

Brief Summary

This prospective observational study aims to evaluate the relationship between anesthesia type and postoperative sleep quality in adult patients undergoing septoplasty. Patients will receive either total intravenous anesthesia or inhalational anesthesia as part of routine clinical care, without any intervention or modification to standard practice. Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire on postoperative days 7 and 15 through structured telephone interviews. Secondary outcomes include postoperative pain intensity, opioid consumption, and postoperative nausea and vomiting. The study seeks to provide real-world evidence on the association between anesthetic approach and posto

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

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

Inclusion Criteria

  • • American Society of Anesthesiologists (ASA) Class I-III
  • Patients aged 18 and over
  • Those who provided written informed consent at the preoperative anesthesia clinic and allowed telephone follow-up on days 2/8.

Exclusion Criteria

  • • ASA Class IV and V
  • Patients under 18 years of age
  • Treatment of severe sleep disorders: Those with severe OSA confirmed by polysomnography and using active CPAP therapy. • Significant cognitive impairment, delirium, active psychotic disorder that prevents reliable completion of scales. • Regular use of hypnotics/benzodiazepines, sedatives/antipsychotics, or chronic opioids (≥3 days/week in the last month), alcohol or substance abuse. • Perioperative complications: Major complications during surgery, unplanned need for intensive care, or reoperation within the first 24 hours. • Pregnancy or breastfeeding. • Severe systemic disease, unstable cardiopulmonary status.

Arms & Interventions

Total Intravenous Anesthesia (TIVA)

Inhalational Anesthesia

Outcomes

Primary Outcomes

Richards-Campbell Sleep Questionnaire (RCSQ) Total Score

Time Frame: Postoperative day 7 and postoperative day 15

Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire. The total RCSQ score is calculated as the mean of five items scored on a 0-100 visual analog scale, with higher scores indicating better sleep quality.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sevim Şenol Karataş
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Sevim Şenol Karataş

Principal Investigator

Elazıg Fethi Sekin Sehir Hastanesi

Study Sites (2)

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