Evaluatıon The Effects Of Anesthesıcs And Surgıcal Treatment On Sleep Qualıty In Patıents That Posterıor Spınal Instrumentatıon Plannıng
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale)
研究概览
简要总结
Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort.
详细描述
Sleep is one of the basic physiological needs of humans. It is necessary for the mind to perform functions such as learning, memory and cognition. Sleep disorders, which can occur for short or long periods in the perioperative period, affect many patients. Studies have shown that approximately 8.8-79.1% of patients experience perioperative sleep disorders, and this situation can continue for a long time after surgery.
According to animal and human studies, anesthetic agents may cause sleep disorders in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause insomnia and poor sleep quality. Since postoperative pain and emotional changes will also cause sleep disturbances, the view that general anesthesia impairs postoperative sleep quality has not yet been proven.
Different types of surgery have varying effects on sleep quality. Patients state that they experience more sleep disruption due to pain, especially after orthopedic surgery. Patients' sleep quality may be even worse due to the greater trauma caused by major surgery. Thoracolumbar posterior instrumentation is a frequently used method in the treatment of spinal instability resulting from spinal trauma, neoplasia, congenital or degenerative diseases. Therefore, we wanted to specifically evaluate this patient group in our study.
Old age, female gender and chronic diseases are among the factors that increase the likelihood of experiencing sleep disorders. Environmental factors and healthcare practices in the hospital may contribute to sleep disturbances. Postoperative environment change, inadequate beds, noise and lights in the ward, medical staff, night treatment and nursing controls, machine noises, postoperative diets and warnings from the urinary catheter are additional factors that affect patients' sleep.
Evaluation of sleep disorders is mainly based on clinical symptoms (difficulty falling asleep, early awakening, night terrors, nightmares or abnormal behavior during the sleep period) and auxiliary objective scales. Subjective sleep quality assessment mainly scales: Pittsburgh Sleep Quality Index questionnaire (PSQI), Pittsburgh Insomnia Rating Scale (PIRS), Insomnia Severity Index (ISI), Athens Insomnia Scale, Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS). The most commonly used assessment in clinical studies is the PSQI. PSQI has high reliability and validity, but evaluates over a one-month period. The PIRS_20 scale, which is a self-assessment survey, is a scale created by the Department of Psychiatry at the University of Pittsburgh and evaluates the sleep quality of participants in the last week. It generally consists of a questionnaire with a total of twenty items, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disorders. Scoring ranges from 0 to 60. A score of 20 and above indicates poor sleep quality, while as the score increases, sleep quality deteriorates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective total hip arthroplasty planning
- •18 years and older patients
- •ASA score between I-III
- •Approved and signed the informed consent form
排除标准
- •Patients under 18 years of age
- •Patients with ASA score 4 and above
- •Patients who do not accept informed consent
- •Those who refuse to participate in the study
研究组 & 干预措施
TIVA group
Patients will be anesthetized with total ıntravenous anesthesia by propofol and remifentanyl infusion. End of the procedure all patients will be extubated and awakened in the operating room. İntravenous morphine patient-controlled analgesia will be used in the postoperative period.
干预措施: Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance (Other)
İnhalation group
Patients will be anesthetized with induction of propofol and sevoflurane (inhalational agent) will be used for maintenance. End of the procedure all patients will be extubated and awakened in the operating room. İntravenous morphine patient-controlled analgesia will be used in the postoperative period.
干预措施: Inhalation anesthesia with sevoflurane for anesthetic maintenance (Other)
结局指标
主要结局
Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale)
时间窗: Preoperative status a month before surgery and a day before surgery and one week postoperatively]
Sleep quality evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) , a scale provides ranging from 0 to 60 , with a high score indicating a poor quality of sleeping.
次要结局
- Subjective pain level(Preoperative status a month before surgery and a day before surgery and one week postoperatively])
- Subjective anxiety level(Preoperative status a month before surgery and a day before surgery and one week postoperatively])
研究者
Elifgül Ulutaş
Specialist
Uludag University
