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

NCT04682782 | Unknown Phase 4

• 1 other identifier: 2020-516
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Intraoperative sufentanil

  For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms.

  24 hours

Secondary Outcomes (4)

• Intraoperative blood pressure

  24 hours

• Intraoperative heart rate

  24 hours

• Intraoperative cardiac index

  24 hours

• Post-operative recovery time

  24 hours

Study Arms (2)

Esketamine

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

Esketamine DRUG

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) .

Esketamine

Saline DRUG

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.

Also known as: Placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, China

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Esketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Min YAN, MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingyu SHI, MD

CONTACT

+8613777564585; shiqinyu_001@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 24, 2020
• Study Start: July 14, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)