COMPARISON OF THE EFFECTS OF GENERAL AND REGIONAL ANESTHESIA ON SLEEP QUALITY IN PATIENTS PLANNING TOTAL HIP ARTROPLASTY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 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
Sleep disorders can impair cognitive function, decision-making ability, exercise capacity, and immune system.Sleep disorders, which may occur in the perioperative period as short-term or long-term, affect many patients. Patients have to face with perioperative sleep disorders, and this situation can continue for a long time after surgery.
Anesthetic agents may cause sleep disturbances in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause sleep insufficiency and poor sleep quality. The relationship between general anesthesia and postoperative sleep disorders is still unclear. It is advantageous to identify patients with pre-existing sleep disorders, since the risk of postoperative sleep disturbance is high.
The investigators hypothesis that regional anesthesia does not disrupt the circadian rhythm compared to general anesthesia, is more successful in pain control, and thus provides a better sleep quality for patients.
详细描述
Sleep is one of the basic physiological needs of man and is necessary for the normal functioning of the body. Sleep disorders can impair cognitive function, decision-making ability, exercise capacity, and immune system. Sleep disorders, which may occur in the perioperative period as short-term or long-term, 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 disturbances in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause sleep insufficiency 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.
Pain is the most important risk factor for sleep disturbance in the perioperative period. There is a very serious interaction between pain and sleep. Pain can exacerbate sleep disorders. At the same time, sleep disorders can make the pain worse. Perioperative pain accompanies physical discomfort and is very common, especially in osteoarthritis patients. The goals of total hip arthroplasty (TKA) include relief of these pains and improvement of physical function.
Different types of surgery have varying effects on sleep quality. Patients report that they experience more sleep disruption due to pain after orthopedic surgery. Depending on the greater trauma caused by major surgery, the sleep quality of the patients may be worse.
The elderly and female gender are more likely to experience sleep disorders. Environmental factors and healthcare practices in the hospital may contribute to sleep disorders. 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.
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)
盲法说明
The investigator completing the questionnaires will not be aware of patient group assignment
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
- •Planning of total hip arthroplasty (primary/redo)
- •Elective procedure planning
- •18 years and older patients
- •ASA score between I-III
- •Approved and signed the informed consent form
排除标准
- •Patients who underwent THA with urgent indication
- •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
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 anxiety level(Preoperative status a month before surgery and a day before surgery and one week postoperatively])
- Subjective pain level(Preoperative status a month before surgery and a day before surgery and one week postoperatively])
研究者
Elifgül Ulutaş
Research assistant
Uludag University