Effect of Dexmedetomidine on Sleep and Fatigue After Major Surgery in Elderly Patients
The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study
This study tests if giving an overnight medication called dexmedetomidine can help older patients sleep better and feel less tired after major lung surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Ziekenhuis Oost-Limburg Academic / other |
| Locations | 1 site (Genk, Limburg) |
| Trial ID | NCT06480539 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of nocturnal dexmedetomidine administration on postoperative sleep quality and fatigue in elderly patients undergoing thoracoscopic lung surgery. It compares the effects of dexmedetomidine to a placebo, aiming to determine if improved sleep can enhance recovery and reduce fatigue after major surgery. The study addresses the common issue of sleep disturbances in older adults post-surgery, which may contribute to delayed recovery and increased morbidity.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 years or older scheduled for thoracoscopic lung surgery.
Not a fit: Patients with significant cardiac issues, uncontrolled hypotension, or those undergoing urgent surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and quality of life for elderly patients by enhancing sleep quality and reducing fatigue.
How similar studies have performed: Previous studies have suggested that dexmedetomidine may improve sleep quality in critically ill patients, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Genk, Limburg
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (Recruiting)
Study contacts
- Study coordinator: Steven Thiessen
- Email: steven.thiessen@zol.be
- Phone: 3289325294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.