Anesthesia Type and Postoperative Sleep Quality in Septoplasty (ANES-SLEEP)

April 21, 2026 updated by: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi

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

This prospective observational study aims to evaluate the association between routinely applied anesthesia techniques and postoperative sleep quality in adult patients undergoing septoplasty. Patients will receive either total intravenous anesthesia or inhalational anesthesia according to standard clinical practice, without any intervention by the investigators. Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire on postoperative days 7 and 15. Secondary outcomes include postoperative pain intensity, opioid consumption, and postoperative nausea and vomiting.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

This study is designed as a prospective, observational cohort study conducted at a single tertiary care center. The study population will consist of adult patients undergoing elective septoplasty for nasal septum deviation. All patients will receive general anesthesia as part of routine clinical care, either using total intravenous anesthesia (TIVA) or inhalational anesthesia, according to the anesthesiologist's standard practice. No randomization or study-related intervention will be performed.

Eligible patients will be enrolled consecutively after providing written informed consent. Demographic data, clinical characteristics, American Society of Anesthesiologists (ASA) physical status, duration of surgery, anesthesia technique, perioperative opioid consumption, and postoperative complications will be recorded prospectively using hospital electronic medical records and standardized case report forms.

Postoperative sleep quality will be evaluated using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated patient-reported outcome measure. Follow-up assessments will be conducted via telephone interviews on postoperative days 7 and 15. Pain intensity will be assessed using the Numerical Pain Rating Scale, and postoperative nausea and vomiting will be evaluated using a standardized ordinal scale.

Study Type

Observational

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

  • Turkey (Türkiye)
    • Merkez
      • Elâzığ, Merkez, Turkey (Türkiye), 23200
        • Elazığ Fethi Sekin City Hospital

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

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients aged 18 years and older who are scheduled to undergo elective septoplasty under general anesthesia. Patients will receive either total intravenous anesthesia or inhalational anesthesia according to routine clinical practice. Only patients who provide written informed consent and agree to postoperative follow-up assessments will be included. The study population will be recruited from a single tertiary care hospital.

Description

Inclusion Criteria:

  • - Adults aged 18 years and older
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective septoplasty under general anesthesia
  • Willing and able to provide written informed consent
  • Agree to postoperative follow-up telephone interviews on postoperative days 7 and 15

Exclusion Criteria:

  • - ASA physical status IV or V
  • Age younger than 18 years
  • Severe obstructive sleep apnea confirmed by polysomnography and requiring active CPAP therapy
  • Significant cognitive impairment, delirium, or active psychiatric disorder preventing reliable questionnaire completion
  • Chronic use of opioids, benzodiazepines, hypnotics, sedatives, or antipsychotic medications (≥3 days per week within the last month)
  • Alcohol or substance abuse
  • Major intraoperative complications, unplanned intensive care unit admission, or reoperation within the first 24 hours
  • Pregnancy or breastfeeding
  • Severe systemic disease or unstable cardiopulmonary condition

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

Cohorts and Interventions

Group / Cohort
Total Intravenous Anesthesia
Patients receiving total intravenous anesthesia as part of routine clinical practice.
Inhalational Anesthesia
Patients receiving inhalational general anesthesia according to routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (RCSQ).

The total RCSQ score ranges from 0 to 100 and is calculated as the mean of five core items.

Higher scores indicate better sleep quality.
Postoperative day 7 and postoperative day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: Postoperative day 7 and postoperative day 15
Postoperative pain intensity will be assessed using the Numerical Pain Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
Postoperative day 7 and postoperative day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elazıg Fethi Sekin Sehir Hastanesi

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.

General Publications

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)

December 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FSH-ANES-SEP-SLEEP-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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