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

E

Elazıg Fethi Sekin Sehir Hastanesi

Status

Enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT07325799
FSH-ANES-SEP-SLEEP-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

72 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Sevim ŞENOL KARATAŞ,, MD

Data sourced from clinicaltrials.gov

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