The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Quality of Recovery (QoR)
研究概览
简要总结
In the aftermath of major surgery, many patients suffer from pain, fatigue, reduced general well-being, and cognitive dysfunction. Another common concern after major surgery is sleep impairment and there is little known about its effect on postoperative morbidity, especially postoperative fatigue and muscle function.
Dexmedetomidine has been shown to possibly improve postoperative sleep quality in critically ill patients. However, whether the administration of dexmedetomidine translates into reduced postoperative fatigue and/or weakness and improved enhanced recovery after surgery by improving sleep, is currently unknown.
The DEXSLEEP study will evaluate the effect of nocturnal administration of dexmedetomidine, as compared to placebo (i.e. no dexmedetomidine), on postoperative quality of recovery, postoperative fatigue and muscle weakness.
详细描述
Due to the increase in life expectancy in the developing world, the number of elderly patients undergoing (major) surgery is expected to increase in the coming years. These elderly patients, even healthy older adults, have a reduced physiologic reserve such that organ systems may be compromised during and after surgical stress, placing them at greater risk of morbidity and mortality after surgery.
A common concern after surgery is sleep impairment. Patients often develop significant sleep disturbances after major surgery and particular elderly patients are more prone to develop sleep disturbances when compared to younger patients. Sleep plays an essential role in the homeostasis of multiple organ systems and cognitive function. A good night sleep is deemed essential for a good functional recovery. Taking this into account, it seems logical that postoperative sleep disturbances could be a contributing factor to postoperative fatigue, which is reported by patients as one of the most distressing symptoms after surgery and is thought to be the chief contributor to delayed recovery after surgery.
The endocrinological surgical response probably plays an essential role in postoperative sleep disturbances experienced by surgical patients by causing (neuro)inflammation. Keeping this in mind, dexmedetomidine might be an interesting pharmacological intervention since it has the ability to attenuate several factors that contribute to postoperative sleep disturbances including the endocrinological surgical stress response. However, whether the nocturnal administration of dexmedetomidine translates into improved postoperative sleep quality after elective major surgery, subsequently reduced postoperative fatigue and muscle weakness, and improved enhanced recovery after surgery by improving sleep, is currently unknown.
Therefore, the main objective of this prospective clinical trial is to evaluate the effect of nocturnal dexmedetomidine on early postoperative outcomes, i.e. quality of recovery, in elderly patients (60 years or older) undergoing major surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 60 years or older;
- •scheduled for thoracoscopic lung surgery.
排除标准
- •lack of informed consent or inability to give informed consent;
- •≥ 2nd-degree atrioventricular block without pacemaker;
- •uncontrolled hypotension (blood pressure < 90/60 mmHg);
- •known hypersensitivity to dexmedetomidine or to any of the excipients;
- •acute cerebrovascular conditions;
- •urgent, not elective surgery.
研究组 & 干预措施
Dexmedetomidine
Nocturnal administration of dexmedetomidine (0.2-1.0 mcg/kg/h) during the first night after surgery. Dexmedetomidine infusion, not preceded by a bolus administration, will be started at 0.4 mcg/kg/h in the intervention group at 8 p.m. the day of surgery. Dexmedetomidine infusion will be titrated every 30 minutes with 0.1 mcg/kg/h steps until a RASS of -1 to -3 (drowsy, light to moderate sedation) is reached. The infusion will be discontinued at 6 a.m. the next morning.
干预措施: Dexmedetomidine (Drug)
Placebo
The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Quality of Recovery (QoR)
时间窗: Pre-operative and postoperative day 1
Quality of Recovery Score (QoR-15 score) is a patient-reported outcome measurement which will be used to assess the early postoperative health status of the patient after surgery and anesthesia, i.e. the quality of recovery. The score is arbitrary and ranges from 0 to 150, the higher the score the better the quality of recovery. QoR-15 will be assessed on day 1 as compared to preoperatively.
次要结局
- Sleep-wake cycle (MCTQ)(3 days before surgery)
- Sleep pattern (CSD)(10 consecutive nights, starting 3 days before surgery)
- Postoperative cognitive impairment(Pre-operative and postoperative day 28)
- Quality of Recovery (QoR)(Pre-operative and postoperative day 3 and day 5)
- Postoperative muscle strength (upper extremity)(Pre-operative and postoperative day 1, day 3 and day 5)
- Postoperative muscle strength (lower extremity)(Pre-operative and postoperative day 3 and day 5)
- Sleeping EEG pattern(First postoperative night)
- Postoperative fatigue - Chalder fatigue questionnaire(Pre-operative and postoperative day 1, day 3, day 5 and day 28)
- Health-related quality of life (EQ-5D)(Pre-operative and postoperative day 28)
- Subjective sleep quality (PSQI)(3 days before surgery and postoperative day 28)
- Postoperative fatigue - Fatigue VAS scale(Pre-operative and postoperative day 1, day 3, day 5 and day 28)
- Subjective sleep quality first night after surgery (RCSQ)(Postoperative day 1)
- Postoperative delirium(Postoperative day 1, day 3 and day 5)