Effect of Esketamine on Conscious State in Patients With pDoC

Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness#a Prospective, Randomized, Exploratory Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Consciousness Disorders; Esketamine
• Intervention / Treatment: Drug: Esketamine; Drug: normal saline

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruquan Han, M.D; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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 various reasons
3. 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
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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: esketamine; 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; 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.
Placebo Comparator: normal saline; Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.	Drug: normal saline; Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coma recovery scale-revised(CRS-R)	The CRS-R ranges from 0 to 23,with a higher score indicating a better state of consciousness.	1,3,6 months after surgery
Full Outline of UnResponsiveness(FOUR)	The FOUR ranges from 0 to 16, with a higher score indicating a better state of consciousness.	3±1 day, 1,3,6 months after surgery
Glasgow coma scale(GCS)	The GCS ranges from 3 to 15,with a higher score indicating a better state of consciousness.	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
Power spectral density		during surgery and 3±1 day after surgery
Burst-suppression ratio		during surgery and 3±1 day after surgery
Spectral edge frequency		during surgery and 3±1 day after surgery
The incidence of perioperative adverse events		3±1 day, 1,3,6 months after surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: lk20240401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No