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

Primary Purpose

Burns

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esketamine
Saline
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • 2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Esketamine

Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
December 3, 2020
Last Updated
December 22, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04682782
Brief Title
Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients
Official Title
Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esketamine
Arm Type
Experimental
Arm Description
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
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Esketamine
Intervention Description
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) .
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative sufentanil
Description
For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Intraoperative blood pressure
Description
For all participants, blood pressure will be recorded and compared between the two arms.
Time Frame
24 hours
Title
Intraoperative heart rate
Description
For all participants, heart rate will be recorded and compared between the two arms.
Time Frame
24 hours
Title
Intraoperative cardiac index
Description
For all participants, cardiac index will be recorded and compared between the two arms.
Time Frame
24 hours
Title
Post-operative recovery time
Description
For all participants, the recovery time of spontaneous breathing will be recorded.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingyu SHI, MD
Phone
+8613777564585
Email
shiqinyu_001@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min YAN, MD
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyu SHI
Phone
+8613777564585
Email
shiqinyu_001@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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