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

Phase 4

• Conditions: Burns
• Interventions: Drug: Saline; Drug: Esketamine

• Registration Number: NCT04682782
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-14
• Status Verified: 2020-12
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Study First Posted: 2020-12-24
• Last Update Posted: 2020-12-24
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	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
Esketamine	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, China; 🇨🇳 Hangzhou, Zhejiang, China