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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04682782

Collaborator

(none)

Enrollment

Location

Arms

5.6

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Drug: Esketamine Drug: Saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 14, 2020

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
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	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) .
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	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. Other Names: Placebo

Arm

Intervention/Treatment

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

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) .

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

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.

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

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

Intraoperative blood pressure [24 hours]
For all participants, blood pressure 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 cardiac index [24 hours]
For all participants, cardiac index 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, China	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Principal Investigator: Min YAN, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04682782

Other Study ID Numbers:

2020-516

First Posted:

Dec 24, 2020

Last Update Posted:

Dec 24, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Burns

Esketamine

Study Results

No Results Posted as of Dec 24, 2020