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Prophylactic Effects of Esketamine in Surgical Patients

NCT05180318 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-04-29

No results posted yet for this study

Summary

Evidences have showing that esketamine has anti-inflammatory and therapeutic effects on depression and cardiac surgery. The investigators' preliminary results suggest that combined prophylactic and therapeutic use of esketamine could decrease the plasma levels of pro-inflammatory cytokines after LPS-induced endotoxemia. The investigators also found that combined prophylactic and therapeutic use of esketamine could attenuate systemic inflammation and inflammatory multi-organ injury in mice after CLP-induced lethal sepsis.

Surgical trauma could elicit a marked inflammatory response with increased expression of pro-inflammatory cytokines, as well as postoperative immunosuppression. However, it remains unclear whether combined prophylactic and therapeutic use of esketamine could improve postoperative immunosuppression and alleviates systemic inflammatory response.

This project aims to study whether combined prophylactic and therapeutic use of esketamine could improve the decreased number of lymphocyte subsets and increased plasma pro-inflammatory cytokines.

Conditions

  • Surgical Injury

Interventions

DRUG

Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION [Spravato]

Esketamine (0.25 mg/kg) will be given intravenously 24-36 hours before surgery (infusion time: 40 min) and immediately after surgery (infusion time: 40 min).

DRUG

0.9% saline

0.9% saline

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Jiancheng Zhang, MD, PhD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180318 on ClinicalTrials.gov