Anesthesia Type and Postoperative Sleep Quality in Septoplasty

NCT07325799 | Withdrawn

• 1 other identifier: FSH-ANES-SEP-SLEEP-2025
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasal Septum Deviation; Septoplasty; Total Intravenous Anesthesia; Postoperative Sleep Quality; Inhalational Anesthesia

Keywords

Total Intravenous Anesthesia; Inhalational Anesthesia; Postoperative Sleep Quality; Richards-Campbell Sleep Questionnaire; Septoplasty

Outcome Measures

Primary Outcomes (1)

• Richards-Campbell Sleep Questionnaire (RCSQ) Total Score

  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 Outcomes (1)

• Postoperative Pain Intensity

  Postoperative day 7 and postoperative day 15

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

Location

Related Publications (3)

• Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.

  PMID: 11227580 BACKGROUND

• Lin D, Huang X, Sun Y, Wei C, Wu A. Perioperative Sleep Disorder: A Review. Front Med (Lausanne). 2021 Jun 7;8:640416. doi: 10.3389/fmed.2021.640416. eCollection 2021.

  PMID: 34164409 BACKGROUND

• Li S, Song B, Li Y, Zhu J. Effects of Intravenous Anesthetics vs Inhaled Anesthetics on Early Postoperative Sleep Quality and Complications of Patients After Laparoscopic Surgery Under General Anesthesia. Nat Sci Sleep. 2021 Mar 15;13:375-382. doi: 10.2147/NSS.S300803. eCollection 2021.

  PMID: 33758567 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 8, 2026
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)