AnesthesiaDRINKNCT05990673
Dose of Remi in Children
A study testing Remimazolam in people with Anesthesia, run by Zhihong LU.
Trial summary
Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2023to 10 Sep 2023
- Phase
- Interventional
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age from 3 to 12 years old
- patients scheduled for surgery under general anesthesia
Who cannot join
- American Society of Anesthesiologists status >=Ⅲ
- Body mass index>=28kg/m2
- patients who cannot cooperate with intravenous anesthesia induction
- patients with risk of difficult airway
- patients who are allergic to benzodiazepines
- patients with delayed neurologic function
About this study
Official title: Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients
Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown.
- Conditions
- Anesthesia
- Being tested
- Remimazolam
- Keywords
- general anesthesia, anesthesia induction, remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called remimazolam besylate
remimazolam is given intravenously
| Study group | Role | What they receive |
|---|---|---|
| remimazolam | Experimental | remimazolam is given for anesthesia induction Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
half effective dosage
the dosage by which half of the patients will be sedated
Measured: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
Secondary outcomes (1)
95% effective dosage
the dosage by which 95% of the patients will be sedated
Measured: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start10 Aug 2023 (estimated)
- Primary completion10 Sep 2023 (estimated)
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990673
- Sponsor's protocol ID
- XJH-A-20230606
- Acronym
- DRINK
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tan H, Lou AF, Wu JE, Chen XZ, Qian XW. Determination of the 50% and 95% Effective Dose of Remimazolam Combined with Propofol for Intravenous Sedation During Day-Surgery Hysteroscopy. Drug Des Devel Ther. 2023 Jun 13;17:1753-1761. doi: 10.2147/DDDT.S406514. eCollection 2023.
PubMed 37333966
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05990673
- Acronym / sponsor ID
- DRINK / XJH-A-20230606
- Conditions
- Anesthesia
- Keywords
- general anesthesia, anesthesia induction, remimazolam
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 10 Sep 2023 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 14 Aug 2023 (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.
Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| remimazolam | Experimental | Drug: Remimazolamremimazolam is given for anesthesia induction |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age from 3 to 12 years old
- patients scheduled for surgery under general anesthesia
Key exclusion criteria (6 listed)
- American Society of Anesthesiologists status >=Ⅲ
- Body mass index>=28kg/m2
- patients who cannot cooperate with intravenous anesthesia induction
- patients with risk of difficult airway
- patients who are allergic to benzodiazepines
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 |
|---|---|---|
| RemimazolamAlso: remimazolam besylateremimazolam is given intravenously | Drug | remimazolam |
Primary outcome
half effective dosage
Time frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
the dosage by which half of the patients will be sedated
1 secondary outcome
95% effective dosage
Time frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Results publication: PubMed 37333966Tan H, Lou AF, Wu JE, Chen XZ, Qian XW. Determination of the 50% and 95% Effective Dose of Remimazolam Combined with Propofol for Intravenous Sedation During Day-Surgery Hysteroscopy. Drug Des Devel Ther. 2023 Jun 13;17:1753-1761. doi: 10.2147/DDDT.S406514. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam in people with Anesthesia, run by Zhihong LU.
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 6 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
half effective dosage (time frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990673, which also lists 1 linked publication.
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 14 Aug 2023.