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.
aged 60 years or older;
scheduled for thoracoscopic lung surgery.
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;
Parallel
Placebo
DrugThe comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.
Dexmedetomidine
DrugNocturnal 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.
Quality of Recovery (QoR)
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.
Sleep-wake cycle (MCTQ)
To evaluate each patient's sleep-wake cycle, the sleep-wake timing will be evaluated with the Munich Chronotype Questionnaire (MCTQ) 3 days before surgery, which will be used to calculate the baseline midpoint sleep and chronotype.
Sleep pattern (CSD)
Sleep will be evaluated with the Consensus Sleep Diary (CSD) to have a more in depth insight into the evolution of sleep pre- and postoperatively. The diary will be filled in daily starting 3 days before surgery until 7 days after surgery.
Postoperative fatigue - Chalder fatigue questionnaire
To assess general fatigue a fatigue questionnaire, the Chalder fatigue questionnaire, will be taken on day 1, day 3, day 5 and day 28 postoperatively and be compared to the preoperative value. The questionnaire consists of 11 items that assess both physical and mental aspects of fatigue. Respondents rate each item ranging from 0 to 3, the scores are then totaled to provide a measure of overall fatigue, a higher score meaning more severe fatigue.
Health-related quality of life (EQ-5D)
The EQ-5D is used for measuring health-related quality of life. EQ-5D provides a simple descriptive profile and a single index value for health status, both can be used to assess the overall health. The descriptive profile consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems, or not able. Respondents select the level that best describes their current health status. The EQ-5D also includes a visual analog scale (VAS) where respondents rate their current health status on a scale from 0 to 100, with 0 being the worst imaginable health state and 100 being the best imaginable health state. The EQ-5D questionnaire will be taken preoperatively and on day 28 postoperatively.
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