NCT06192615

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.

Conditions

• Delirium

Interventions

Type	Name	Description
DRUG	Intravenous Dexmedetomidine	Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
DRUG	Sublingual Dexmedetomidine	Sublingual dexmedetomidine (120 μg)
DRUG	Intravenous Placebo	Intravenous placebo of 0.9% saline administered over 40 minutes
DRUG	Sublingual Placebo	Inert sublingual film

Timeline

• Start date: 2025-01-06
• Primary completion: 2027-10-31
• Completion: 2029-03-31
• First posted: 2024-01-05
• Last updated: 2025-12-31

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study