Clinical TrialNeurological InjuryEsketaminePlaceboRecruiting

Effect of Esketamine on Conscious State in Patients With pDoC

Randomised, quadruple-blind, parallel-group trial (n=116) assessing intraoperative IV esketamine 0.3 mg/kg versus saline on consciousness measures in patients with prolonged disorders of consciousness undergoing surgery under sevoflurane anaesthesia.

Target Enrollment
116 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

This parallel, randomised, quadruple-blind study will compare a single intraoperative IV infusion of subanaesthetic esketamine (0.3 mg/kg over 30 minutes) to matched normal saline in patients with prolonged disorders of consciousness undergoing surgery under sevoflurane anaesthesia.

Primary and secondary assessments include Coma Recovery Scale–Revised, Glasgow Coma Scale, Full Outline of UnResponsiveness scores, SedLine multichannel EEG measures and perioperative adverse events; outcomes measured acutely and in the perioperative period.

Study Protocol

Preparation

sessions

Dosing

1 sessions
30 min each

Integration

sessions

Study Arms & Interventions

Esketamine

experimental

Intravenous esketamine 0.3 mg/kg infused over 30 minutes after tracheal intubation.

Interventions

  • Esketamine0.3 mg/kg
    via IV• single dose• 1 doses total

    50 mg vial dissolved in 50 ml saline; infused over 30 min within 30 min after intubation.

Normal saline

placebo comparator

Placebo comparator: same volume of normal saline infused at same rate.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    50 ml normal saline infused over 30 min within 30 min after intubation (placebo comparator).

Participants

Ages
16 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. 16-65 years old
  • 2. Native Chinese language
  • 3. Prolonged disorders of consciousness (pDoC) after acquired brain injury
  • 4. Scheduled to undergo surgery with general anaesthesia
  • 5. Signed informed consent

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Continuous sedation treatment within 72 hours before the study
  • 2. Airway stenosis or severe ventilation/ventilation dysfunction
  • 3. Known or suspected serious cardiac, pulmonary or renal dysfunction: severe cardiac dysfunction (unstable coronary syndrome; congestive heart failure with LVEF <50% or elevated BNP; severe arrhythmia; history of severe valvular disease); severe pulmonary dysfunction (history of pulmonary heart disease; COPD); severe renal dysfunction (Ccr <30 ml/min or GFR <30 ml/min·1.73m2)
  • 4. Allergic history to sedative drugs
  • 5. Combined with other mental or nervous system diseases
  • 6. Other reasons rendering the participant unsuitable for the study

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment116 participants
  • Timeline
    Start: 2024-05-01
    End: 2026-06-30
  • Compounds
    EsketaminePlacebo
  • Topic
    Neurological Injury

Locations

Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China

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