Anesthesia Type and Postoperative Sleep Quality in Septoplasty

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07325799

Acronym

ANES-SLEEP

Enrollment

Registered

2026-01-08

Start date

2025-12-01

Completion date

2026-03-01

Last updated

2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Richards-Campbell Sleep Questionnaire (RCSQ) Total Score	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.

Secondary

Measure	Time frame	Description
Postoperative Pain Intensity	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).

Countries

Turkey (Türkiye)

Outcome results