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临床试验/NCT07416773
NCT07416773已完成不适用

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

Sevim Şenol Karataş1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年11月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Richards-Campbell Sleep Questionnaire (RCSQ) Total Score

研究概览

简要总结

This prospective observational study aims to evaluate the relationship between anesthesia type and postoperative sleep quality in adult patients undergoing septoplasty. Patients will receive either total intravenous anesthesia or inhalational anesthesia as part of routine clinical care, without any intervention or modification to standard practice. Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire on postoperative days 7 and 15 through structured telephone interviews. Secondary outcomes include postoperative pain intensity, opioid consumption, and postoperative nausea and vomiting. The study seeks to provide real-world evidence on the association between anesthetic approach and posto

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • American Society of Anesthesiologists (ASA) Class I-III
  • Patients aged 18 and over
  • Those who provided written informed consent at the preoperative anesthesia clinic and allowed telephone follow-up on days 2/8.

排除标准

  • • ASA Class IV and V
  • Patients under 18 years of age
  • Treatment of severe sleep disorders: Those with severe OSA confirmed by polysomnography and using active CPAP therapy. • Significant cognitive impairment, delirium, active psychotic disorder that prevents reliable completion of scales. • Regular use of hypnotics/benzodiazepines, sedatives/antipsychotics, or chronic opioids (≥3 days/week in the last month), alcohol or substance abuse. • Perioperative complications: Major complications during surgery, unplanned need for intensive care, or reoperation within the first 24 hours. • Pregnancy or breastfeeding. • Severe systemic disease, unstable cardiopulmonary status.

研究组 & 干预措施

Total Intravenous Anesthesia (TIVA)

Inhalational Anesthesia

结局指标

主要结局

Richards-Campbell Sleep Questionnaire (RCSQ) Total Score

时间窗: Postoperative day 7 and postoperative day 15

Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire. The total RCSQ score is calculated as the mean of five items scored on a 0-100 visual analog scale, with higher scores indicating better sleep quality.

次要结局

未报告次要终点

研究者

发起方
Sevim Şenol Karataş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sevim Şenol Karataş

Principal Investigator

Elazıg Fethi Sekin Sehir Hastanesi

研究点 (1)

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