NCT06480539 The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study
| NCT ID | NCT06480539 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ziekenhuis Oost-Limburg |
| Condition | Postoperative Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 102 participants in total. It began in 2024-06-06 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06480539 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Postoperative Fatigue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06480539 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06480539 currently recruiting?
Yes, NCT06480539 is actively recruiting participants. Contact the research team at steven.thiessen@zol.be for enrollment information.
Where is the NCT06480539 trial being conducted?
This trial is being conducted at Genk, Belgium.
Who is sponsoring the NCT06480539 clinical trial?
NCT06480539 is sponsored by Ziekenhuis Oost-Limburg. The trial plans to enroll 102 participants.