Clinical trial NCT06480539: The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study
Official title: The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Fatigue
Postoperative Sleep Disturbances
Surgical Stress Response
Keywords: Major surgery
Enhanced Recovery After Surgery (ERAS)
Elderly patients
Quality of recovery
Postoperative fatigue
Postoperative muscle weakness
Postoperative sleep disturbances
Dexmedetomidine
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* aged 60 years or older;
* scheduled for thoracoscopic lung surgery.

Exclusion Criteria:

* lack of informed consent or inability to give informed consent;
* ≥ 2nd-degree atrioventricular block without pacemaker;
* uncontrolled hypotension (blood pressure \&lt; 90/60 mmHg);
* known hypersensitivity to dexmedetomidine or to any of the excipients;
* acute cerebrovascular conditions;
* urgent, not elective surgery.

Primary outcomes:
measure: Quality of Recovery (QoR)
timeFrame: Pre-operative and postoperative day 1
Secondary outcomes:
measure: Sleep-wake cycle (MCTQ)
timeFrame: 3 days before surgery
measure: Sleep pattern (CSD)
timeFrame: 10 consecutive nights, starting 3 days before surgery
measure: Postoperative fatigue - Chalder fatigue questionnaire
timeFrame: Pre-operative and postoperative day 1, day 3, day 5 and day 28
measure: Health-related quality of life (EQ-5D)
timeFrame: Pre-operative and postoperative day 28
measure: Subjective sleep quality (PSQI)
timeFrame: 3 days before surgery and postoperative day 28
measure: Postoperative fatigue - Fatigue VAS scale
timeFrame: Pre-operative and postoperative day 1, day 3, day 5 and day 28
measure: Subjective sleep quality first night after surgery (RCSQ)
timeFrame: Postoperative day 1
measure: Postoperative delirium
timeFrame: Postoperative day 1, day 3 and day 5
measure: Postoperative cognitive impairment
timeFrame: Pre-operative and postoperative day 28
measure: Quality of Recovery (QoR)
timeFrame: Pre-operative and postoperative day 3 and day 5
measure: Postoperative muscle strength (upper extremity)
timeFrame: Pre-operative and postoperative day 1, day 3 and day 5
measure: Postoperative muscle strength (lower extremity)
timeFrame: Pre-operative and postoperative day 3 and day 5
measure: Sleeping EEG pattern
timeFrame: First postoperative night
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References: