Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness

NCT ID: NCT06473285

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-05-30

Brief Summary

Prolonged disorders of consciousness (pDoC) are pathologies in which there is a loss of consciousness for more than 28 days. The number of patients with pDoC is increasing as the level of critical care treatment and monitoring improves. However, clinical trials for patients with pDoC are limited by small sample sizes, lack of placebo groups, and use of heterogeneous outcome measures. As a result, few therapies have strong evidence to support their use. In recent years, ketamine has been used with remarkable success in the treatment of neuropsychiatric disorders by inducing neuroplasticity, increasing neurophysiologic complexity, and expanding functional brain connectivity states. Considering increased brain plasticity as well as brain complexity, it may be beneficial for consciousness recovery. In this study, the investigators aimed to explore the effects of esketamine on brain networks and level of consciousness in patients with pDoC, and to discuss its possible use as a wakefulness-promoting treatment for patients with pDoC.

Conditions

Prolonged Disorders of Consciousness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy brain volunteers

Group Type: ACTIVE_COMPARATOR

Drug: Esketamine (Continuous infusion)

Intervention Type: DRUG

Continuous intravenous infusion of ketamine at a dose of 0.3mg/(kg · h). Collect resting state EEG and auditory event-related potential (ERP) before administration (baseline), 60 minutes after administration, 30 and 60 minutes after discontinuation.

Patients with prolonged disorders of consciousness

Group Type: EXPERIMENTAL

Drug: Esketamine (Continuous infusion)

Intervention Type: DRUG

Continuous intravenous infusion of ketamine at a dose of 0.3mg/(kg · h). Collect resting state EEG and auditory event-related potential (ERP) before administration (baseline), 60 minutes after administration, 30 and 60 minutes after discontinuation.

Interventions

Drug: Esketamine (Continuous infusion)

Continuous intravenous infusion of ketamine at a dose of 0.3mg/(kg · h). Collect resting state EEG and auditory event-related potential (ERP) before administration (baseline), 60 minutes after administration, 30 and 60 minutes after discontinuation.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 - 65 years old, native Chinese speaker, dextromanual;
• Chronic disorder of consciousness;
• Spinal cord electrical stimulator implantation under general anesthesia;
• Signed informed consent.

• Age 18 - 65 years old;
• Patients undergoing surgical treatment under elective general anaesthesia;
• American Society of Anesthesiologists (ASA) I-II;
• Native Chinese speaker;
• Dextromanual;
• Signed informed consent.

Exclusion Criteria

• Continuous sedation was administered within 72 hours prior to the study;
• Open head injury, parenchymal resection and other damage of brain structural integrity;
• The intracranial compliance decreased due to hydrocephalus and swelling;
• Known hearing impairment;
• Airway stenosis and various causes of severe ventilation or ventilation dysfunction;
• Known or suspected severe cardiac, pulmonary, hepatic, and renal dysfunction;
• History of drug allergy to esketamine;
• Associated with other mental or neurological diseases;
• Other reasons are not suitable to participate in this study.

Healthy brain volunteers:

• Previous history of craniocerebral disease, imaging suggests organic brain lesions;
• People with uncontrolled hypertension, hyperthyroidism, elevated intracranial pressure, epileptic seizures;
• History of drug allergy to esketamine;
• Hearing abnormality;
• History of drug and alcohol abuse;
• People with mental and behavioral disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Head of anesthesiology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ruquan Han, M.D., Ph.D

Role: primary

ruquan.han@gmail.com

8610-59976660

Other Identifiers

LY20240424

Identifier Type: -

Identifier Source: org_study_id