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Clinical trial

The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study

ID
Name
Z-2023104
Description
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.
Trial arms
Trial start
2024-06-06
Estimated PCD
2025-11-01
Trial end
2025-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Placebo
The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.
Arms:
Placebo
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.
Arms:
Dexmedetomidine
Size
102
Primary endpoint
Quality of Recovery (QoR)
Pre-operative and postoperative day 1
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 \< 90/60 mmHg); * known hypersensitivity to dexmedetomidine or to any of the excipients; * acute cerebrovascular conditions; * urgent, not elective surgery.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 102, 'type': 'ESTIMATED'}}
Updated at
2024-06-28

1 organization

1 product

1 drug

3 indications

Organization
Ziekenhuis Oost-Limburg
Drug
Varlilumab
Indication
Postoperative Fatigue
Indication
Postoperative Sleep Disturbances
Indication
Surgical Stress Response
Product
Dexmedetomidine