Clinical Trial

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

Study acronym: DEXSLEEP
Recruiting Phase 4
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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.
Protocol Amendment History 1 change
notable Primary completion pushed: 2026-03 -> 2026-04-01 2026-04-09
Trial Details
NCT Number NCT06480539
Lead Sponsor Ziekenhuis Oost-Limburg
Conditions Postoperative Fatigue, Postoperative Sleep Disturbances, Surgical Stress Response
Enrollment 102 participants
Start Date 2024-06-06
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-08