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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Postoperative Fatigue, Postoperative Sleep Disturbances, Surgical Stress Response

In brief

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.

Key facts

Study ID

NCT06480539

Run by

Ziekenhuis Oost-Limburg

People needed

102

Starts

2024-06-06

Expected to finish

2026-04-01

Last updated by the study team

2026-04-08

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (enrolling)

Full record on ClinicalTrials.gov

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