Effect of Esketamine on Conscious State in Patients With pDoC

Last updated: July 29, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

normal saline

Esketamine

Clinical Study ID

NCT06389344
lk20240401
  • Ages 16-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

1.16-65 years old 2.Native Chinese language 3.pDoC after acquired brain injury 4.Scheduled to undergo surgery 5.Signed informed consent

Exclusion

Exclusion Criteria:

  1. Continuous sedation treatment was carried out within 72 hours before the study

  2. Airway stenosis and severe ventilation or ventilation dysfunction caused by variousreasons

  3. Known or suspected to have serious cardiac, pulmonary and renal dysfunction 1)Severecardiac dysfunction: a. unstable coronary syndrome b. Congestive heart failure: leftventricular ejection fraction less than 50%, elevated BNP c.Severe arrhythmia d.History of severe valvular disease 2)Severe pulmonary dysfunction: a. history ofpulmonary heart disease b. History of chronic obstructive pulmonary disease 3)Severerenal dysfunction: a. Endogenous creatinine clearance (Ccr) less than 30ml/min b.The glomerular filtration rate (GFR) was less than 30ml/min•1.73m2

  4. Allergic history of sedative drugs

  5. Combined with other mental or nervous system diseases

  6. Other reasons are not suitable for this study.

Study Design

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: normal saline
Phase:
Study Start date:
May 20, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100070
    China

    Active - Recruiting

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