Evaluation of the Association Between Anesthesia Type and Postoperative Sleep Quality in Septoplasty Patients: A Prospective Observational Study
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Richards-Campbell Sleep Questionnaire (RCSQ) Total Score
Overview
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.
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
- •\- 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
Arms & Interventions
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.
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 (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 Outcomes
- Postoperative Pain Intensity(Postoperative day 7 and postoperative day 15)
Investigators
Sevim Şenol Karataş
Anesthesiology and Reanimation Specialist
Elazıg Fethi Sekin Sehir Hastanesi