Effect of Esketamine on Conscious State in Patients With pDoC

Esketamine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389344
• Other study ID #: lk20240401
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, M.D
• Phone: 8610-59976660
• Email: ruquan.han[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Esketamine

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Original EEG		during surgery and 3±1 day after surgery
Secondary	Patient state index(PSI)		during surgery and 3±1 day after surgery
Secondary	Power spectral density		during surgery and 3±1 day after surgery
Secondary	Burst-suppression ratio		during surgery and 3±1 day after surgery
Secondary	Spectral edge frequency		during surgery and 3±1 day after surgery
Secondary	The incidence of perioperative adverse events		3±1 day, 1,3,6 months after surgery