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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04682782
• Other study ID #: 2020-516
• Status: Recruiting
• Phase: Phase 4
• Start date: July 14, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qingyu SHI, MD
• Phone: +8613777564585
• Email: shiqinyu_001[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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) .
• 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.

Locations

Country	Name	City	State
China	2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative sufentanil	For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms.	24 hours
Secondary	Intraoperative blood pressure	For all participants, blood pressure will be recorded and compared between the two arms.	24 hours
Secondary	Intraoperative heart rate	For all participants, heart rate will be recorded and compared between the two arms.	24 hours
Secondary	Intraoperative cardiac index	For all participants, cardiac index will be recorded and compared between the two arms.	24 hours
Secondary	Post-operative recovery time	For all participants, the recovery time of spontaneous breathing will be recorded.	24 hours