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NCT06648681: PROTEX
Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients
Phase 2 trial testing Lemborexant 5 mg in Delirium - Postoperative in 60 participants. Not yet recruiting.
30 April 2027
Quick facts
| Lead sponsor | University of British Columbia |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 May 2025 |
| Primary completion | 30 April 2027 |
| Estimated completion | 30 April 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Lemborexant 5 mg — full drug profile →
- Control (placebo) group
Conditions studied
- Delirium - Postoperative — all drugs for Delirium - Postoperative →
- Cardiac Surgery — all drugs for Cardiac Surgery →
- Cardiac Surgery Subjects — all drugs for Cardiac Surgery Subjects →
- Orexin Antagonist — all drugs for Orexin Antagonist →
Sponsor
University of British Columbia
Who can join
61 and older, any sex, with Delirium - Postoperative or Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dual Orexin Receptor Antagonists for Delirium: A Scoping Review and Feasibility Trial of Daridorexant.
Oldham MA, Lander HL, Choi JJ, Gloff MS, et al · · 2026 · cited 4× · PMID 40374039 · DOI 10.1016/j.jaclp.2025.05.003
Verify or expand the search:
- PubMed search for NCT06648681
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lemborexant 5 mg
Trials testing the same drug.
- NCT03001557 — Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia · Phase 2 · completed
- NCT02350309 — Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participan · Phase 1 · completed
Other recruiting trials for Delirium - Postoperative
Currently open trials in the same condition.
- NCT07411612 — The Association Between Postoperative Inflammatory and Neurological Serum Biomarker Concentrations and Occurrence of Pos · recruiting
- NCT07323940 — Correlation Between Perioperative EEG Variability and Postoperative Delirium Incidence. · recruiting
- NCT06861998 — Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery · NA · recruiting
- NCT06879431 — Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery · NA · recruiting
- NCT06894238 — Electroencephalogram Predicts Post-operative Delirium · recruiting
Other University of British Columbia trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06648681 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of British Columbia
- Last refreshed: 23 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06648681.
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