Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
Location status: Recruiting
Location contact
Ruquan Han, MD,PhD
CONTACT
Ruquan Han, MD,PhD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06389344
Effect of Esketamine on Conscious State in Patients With pDoC
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
16 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
- 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.
Treatment and study plan
Esketamine
DrugEsketamine ( 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
DrugSame amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
Primary outcomes
-
Coma recovery scale-revised(CRS-R)
Time frame: 3±1 day after surgery
The CRS-R ranges from 0 to 23, with a higher score indicating a better state of consciousness.
Secondary outcomes
-
Coma recovery scale-revised(CRS-R)
Time frame: 1,3,6 months after surgery
The CRS-R ranges from 0 to 23,with a higher score indicating a better state of consciousness.
-
Full Outline of UnResponsiveness(FOUR)
Time frame: 3±1 day, 1,3,6 months after surgery
The FOUR ranges from 0 to 16, with a higher score indicating a better state of consciousness.
-
Glasgow coma scale(GCS)
Time frame: 3±1 day, 1,3,6 months after surgery
The GCS ranges from 3 to 15,with a higher score indicating a better state of consciousness.
-
Original EEG
Time frame: during surgery and 3±1 day after surgery
-
Patient state index(PSI)
Time frame: during surgery and 3±1 day after surgery
-
Power spectral density
Time frame: during surgery and 3±1 day after surgery
-
Burst-suppression ratio
Time frame: during surgery and 3±1 day after surgery
-
Spectral edge frequency
Time frame: during surgery and 3±1 day after surgery
-
The incidence of perioperative adverse events
Time frame: 3±1 day, 1,3,6 months after surgery
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Beijing Tiantan Hospital
Other
Registry information
Official study title
Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness#a Prospective, Randomized, Exploratory Study
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Apr 29, 2024
- Registry last updated
- Jul 30, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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