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Recruiting Phase 4 NCT06480539

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

Trial Parameters

Condition Postoperative Fatigue
Sponsor Ziekenhuis Oost-Limburg
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 102
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2024-06-06
Completion 2026-03
Interventions
PlaceboDexmedetomidine

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.

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.

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