Actively Recruiting

Phase Not Applicable
Age: 16Years - 65Years
All Genders
NCT06389344

Effect of Esketamine on Conscious State in Patients With pDoC

Led by Beijing Tiantan Hospital · Updated on 2024-07-30

116

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Effect of Esketamine on Conscious State in Patients With pDoC

Who Can Participate

Age: 16Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 65 years
  • Native Chinese language speakers
  • Diagnosed with prolonged disorders of consciousness after acquired brain injury
  • Scheduled for surgery
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Continuous sedation treatment within 72 hours before the study
  • Airway narrowing or severe breathing problems
  • Serious heart problems including unstable coronary syndrome, congestive heart failure with left ventricular ejection fraction less than 50%, elevated BNP, severe arrhythmia, or severe valvular disease
  • Severe lung problems such as pulmonary heart disease or chronic obstructive pulmonary disease
  • Severe kidney problems with creatinine clearance less than 30 ml/min or glomerular filtration rate less than 30 ml/min/1.73m2
  • Allergy to sedative drugs
  • Presence of other mental or nervous system diseases
  • Other conditions making participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

R

Ruquan Han, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of Esketamine on Conscious State in Patients With pDoC | DecenTrialz