Effect of Esketamine on Conscious State in Patients With pDoC

This interventional trial (n=116) will investigate the effect of intraoperative infusion of a subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness (pDoC) under sevoflurane anaesthesia.

The study, led by Dr. Ruquan Han at Beijing Tiantan Hospital, aims to understand the impact of esketamine on conscious states in patients with pDoC undergoing surgery. Participants aged 16 to 65 and experiencing pDoC after acquired brain injury will receive either esketamine or normal saline intravenously during surgery.

Outcome measures include assessing consciousness using the Coma Recovery Scale-Revised (CRS-R), Glasgow Coma Scale (GCS), Full Outline of UnResponsiveness (FOUR) scores, SedLine multi-channel electroencephalogram, and perioperative adverse events. The trial is estimated to begin in May 2024 and complete by June 30, 2026.

Topic Traumatic Brain Injury
Compound Ketamine Placebo
Country China
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 May 2024
End date 30 June 2026
Phase Not Applicable
Design Blinded
Type Interventional
Generation First
Participants 116
Sex All
Age 16- 65
Therapy No

Trial Details

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.

NCT Number NCT06389344

Sponsors & Collaborators

Beijing TianTan Hospital
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Data attribution

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