NCT06389344

Effect of Esketamine on Conscious State in Patients With pDoC

Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness#a Prospective, Randomized, Exploratory Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia. Participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated.

Conditions

• Esketamine
• Consciousness Disorders

Interventions

Type	Name	Description
DRUG	Esketamine	Esketamine ( 50mg, dissolved in 50ml normal saline ) 0.3mg / kg will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
DRUG	normal saline	Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-04-29
• Last updated: 2024-07-30

Locations

1 site across 1 country: China