BurnsPhase 4NCT04682782
Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients
A Phase 4 study testing Esketamine and Saline in people with Burns, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Esketamine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2020to 30 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All intubated adult burn patients( age>18 ), presenting to the operating room;
- Burn area> 30%.
Who cannot join
- Allergy to Esketamine or benzodiazepines
- Esketamine or ketamine use in the preceding 24 hours
- Increased intracranial pressure
- Increased intraocular pressure
- Porphyria
- Thyroid disorders
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, China
Hangzhou, Zhejiang, 310003
Qingyu SHI, +8613777564585, shiqinyu_001@zju.edu.cn
About this study
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
- Being tested
- Esketamine, Saline
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
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) .
SalineDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative sufentanil
For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms.
Measured: 24 hours
Secondary outcomes (4)
Intraoperative blood pressure
For all participants, blood pressure will be recorded and compared between the two arms.
Measured: 24 hours
Intraoperative heart rate
For all participants, heart rate will be recorded and compared between the two arms.
Measured: 24 hours
Intraoperative cardiac index
For all participants, cardiac index will be recorded and compared between the two arms.
Measured: 24 hours
Post-operative recovery time
For all participants, the recovery time of spontaneous breathing will be recorded.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start14 Jul 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min YAN, MD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682782
- Sponsor's protocol ID
- 2020-516
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients
- ClinicalTrials.gov ID
- NCT04682782
- Acronym / sponsor ID
- 2020-516
- Conditions
- Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine | Experimental | Drug: EsketamineParticipants 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 |
| Saline | Placebo comparator | Drug: SalineParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All intubated adult burn patients( age>18 ), presenting to the operating room;
- Burn area> 30%.
Key exclusion criteria (9 listed)
- Allergy to Esketamine or benzodiazepines
- Esketamine or ketamine use in the preceding 24 hours
- Increased intracranial pressure
- Increased intraocular pressure
- Porphyria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineEsketamine 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) . | Drug | Esketamine |
| SalineAlso: PlaceboParticipants 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. | Drug | Saline |
Primary outcome
Intraoperative sufentanil
Time frame: 24 hours
For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms.
4 secondary outcomes
Intraoperative blood pressure
Time frame: 24 hours
Intraoperative heart rate
Time frame: 24 hours
Intraoperative cardiac index
Time frame: 24 hours
Post-operative recovery time
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min YAN, MD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine and Saline in people with Burns, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingyu SHI, MD (+8613777564585, shiqinyu_001@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative sufentanil (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.