Effect of Esketamine on Conscious State in Patients With pDoC

NCT06389344 | Recruiting

• 1 other identifier: lk20240401
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Coma recovery scale-revised(CRS-R)

  The CRS-R ranges from 0 to 23, with a higher score indicating a better state of consciousness.

  3±1 day after surgery

Secondary Outcomes (9)

• Coma recovery scale-revised(CRS-R)

  1,3,6 months after surgery

• Full Outline of UnResponsiveness(FOUR)

  3±1 day, 1,3,6 months after surgery

• Glasgow coma scale(GCS)

  3±1 day, 1,3,6 months after surgery

• Original EEG

  during surgery and 3±1 day after surgery

• Patient state index(PSI)

  during surgery and 3±1 day after surgery

Study Arms (2)

esketamine

EXPERIMENTAL

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: Esketamine

normal saline

PLACEBO COMPARATOR

Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.

Drug: normal saline

Interventions

Esketamine DRUG

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.

esketamine

normal saline DRUG

Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.

normal saline

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Continuous sedation treatment was carried out within 72 hours before the study
• Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
• Known or suspected to have serious cardiac, pulmonary and renal dysfunction 1)Severe cardiac dysfunction: a. unstable coronary syndrome b. Congestive heart failure: left ventricular ejection fraction less than 50%, elevated BNP c.Severe arrhythmia d. History of severe valvular disease 2)Severe pulmonary dysfunction: a. history of pulmonary heart disease b. History of chronic obstructive pulmonary disease 3)Severe renal dysfunction: a. Endogenous creatinine clearance (Ccr) less than 30ml/min b. The glomerular filtration rate (GFR) was less than 30ml/min•1.73m2
• Allergic history of sedative drugs
• Combined with other mental or nervous system diseases
• Other reasons are not suitable for this study.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ruquan Han, M.D

CONTACT

8610-59976660; ruquan.han@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 29, 2024
• Study Start: May 20, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CN (1)