Evaluation of the Analgesic-Sedative and Neuroprotective Effects and Safety of Esketamine Combined with Propofol in Patients with Severe Traumatic Brain Injury

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600120393

Enrollment

Unknown

Registered

2026-03-13

Start date

2025-06-01

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury

Interventions

Control Group:Remifentanil + Propofol for Analgesia and Sedation

Test group:Ketamine + Propofol for Analgesia and Sedation

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 and 92%, the set inhaled oxygen concentration of the ventilator <= 60%, and positive end - expiratory pressure <= 10 cmH2O; 7. Patients expected to require ICU treatment for more than 3 days.

Exclusion criteria

Exclusion criteria: 1. Patients with non-severe traumatic brain injury; 2. patients aged 65 years; 3. Patients with an expected death within the next 24 hours; 4. Patients with persistent intracranial pressure >22 mmHg; 5. Pregnant or lactating patients; 6. Patients with contraindications to esketamine use (uncontrolled hypertension, SBP >180 mmHg, DBP >100 mmHg); 7. Patients with contraindications to remifentanil or propofol use; 8. Patients with allergies to esketamine, remifentanil, or propofol; 9. Patients with a history of neurological or psychiatric disorders; 10. Patients with decompensated heart failure (EF 60% inspired oxygen concentration or >10 cmH2O ventilator support; 12. Patients with heart rate >130 BPM, systolic blood pressure 0.2 µg/kg/min, and evidence of significant bleeding, or those with ruptured aortic aneurysm; 13. Creatinine clearance <30 mL/min; 14. Patients with end-stage liver disease; 15. Patients unable to complete study-related assessments; 16. History of drug or alcohol abuse; 17. Refusal to sign the informed consent form; 18. Currently participating in another drug clinical trial or having participated in another clinical trial within the past 30 days.

Design outcomes

Primary

Measure	Time frame
Electroencephalogram,EEG;Pulsatility Index,PI;end of diastolic velocity, EDV;peak systolic velocity, PSV;mean velocity, MV;Resistive Index,RI;	—

Countries

China

Contacts

Public ContactChengli Wen

The Affiliated Hospital of Southwest Medical University

wenchengli076@swmu.edu.cn+86 19150872881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026