Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients

Overview

This study aim to determine whether a small-dose esketamine infusion can be used for pain control in severe burn patients, and thereby reduce the total intra-operative opioid requirement. Secondary objectives are to determine whether this low-dose esketamine infusion will increase the stability of circulation.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 30, 2020

Interventions

  • Drug: Esketamine
    • Esketamine is infused through the whole period of surgery. Participants randomized to the esketamine arm will receive 1 mg/ml solution infused at 0.1 mg/kg/hour (0.1 ml/kg/h) .
  • Drug: Saline
    • Participants randomized to the placebo arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.1 ml/kg/hour throughout the surgery.

Arms, Groups and Cohorts

  • Experimental: Esketamine
    • Participants randomized to this arm will receive Esketamine (1 mg/ml) infused at 0.1 mg/kg/hour (0.1 ml/kg/h) throughout the operation
  • Placebo Comparator: Saline
    • Participants randomized to this arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.1 ml/kg/hour throughout the operation

Clinical Trial Outcome Measures

Primary Measures

  • Intraoperative sufentanil
    • Time Frame: 24 hours
    • For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms.

Secondary Measures

  • Intraoperative blood pressure
    • Time Frame: 24 hours
    • For all participants, blood pressure will be recorded and compared between the two arms.
  • Intraoperative heart rate
    • Time Frame: 24 hours
    • For all participants, heart rate will be recorded and compared between the two arms.
  • Intraoperative cardiac index
    • Time Frame: 24 hours
    • For all participants, cardiac index will be recorded and compared between the two arms.
  • Post-operative recovery time
    • Time Frame: 24 hours
    • For all participants, the recovery time of spontaneous breathing will be recorded.

Participating in This Clinical Trial

Inclusion Criteria

  • All intubated adult burn patients( age>18 ), presenting to the operating room; – Burn area> 30%. Exclusion Criteria:

  • Allergy to Esketamine or benzodiazepines – Esketamine or ketamine use in the preceding 24 hours – Increased intracranial pressure – Increased intraocular pressure – Porphyria – Thyroid disorders – Seizures – Acute myocardial ischemia – Children (patients under age 18), prisoners, pregnant or breastfeeding women, patients with psychosis, patients with developmental delay, and any condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the trial endpoints.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Min YAN, MD, Principal Investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
  • Overall Contact(s)
    • Qingyu SHI, MD, +8613777564585, shiqinyu_001@zju.edu.cn

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