AnesthesiaDRIPNCT06170918
Dose of Remimazolam in Children for Intubation
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, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl 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
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 31 May 2024
- 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
- Body mass index in the range of 5% -95% of the same age group
- Consent was obtained from the patient and the family members, and an informed consent form was signed
Who cannot join
- American Society of Anesthesiologists status ≥3
- patients who cannot cooperate with intravenous anesthesia induction
- patients with risk of difficult airway
- patients who are allergic to benzodiazepines
- patients with neurological dysfunction
- Participate involved in other clinical investigators within 3 months
About this study
Official title: Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl
Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl in pediatric patients is still unknown.
- Conditions
- Anesthesia
- Being tested
- Remimazolam
- Keywords
- anesthesia induction, remimazolam, tracheal intubation, median effective dose
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. The initial dosage is 0.4mg/kg, and the interval dosage is 0.02mg/kg. Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
half effective dose for intubation
half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl
Measured: from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes
cardiovascular response to tracheal intubation
cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation
Measured: from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes
Secondary outcomes (2)
the time to loss of consciousness
Measured: from injection of remimazolam to loss of consciousness, at an average of 3 minutes
incidence of adverse events
adverse events include bradycardia, hypotension, hypoxemia, and injection pain
Measured: from injection of remimazolam to loss of consciousness, at an average of 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06170918
- Sponsor's protocol ID
- XJH-A-20231120
- Acronym
- DRIP
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fang YB, Wang CY, Gao YQ, Cai YH, Chen J, Zhang XL, Dong LQ, Shang-Guan WN, Liu HC. The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: Study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial. Front Pharmacol. 2023 Feb 10;14:1090608. doi: 10.3389/fphar.2023.1090608. eCollection 2023.
PubMed 36843931Kimoto Y, Hirano T, Kuratani N, Cavanaugh D, Mason KP. Remimazolam as an Adjunct to General Anesthesia in Children: Adverse Events and Outcomes in a Large Cohort of 418 Cases. J Clin Med. 2023 Jun 8;12(12):3930. doi: 10.3390/jcm12123930.
PubMed 37373624
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl
- ClinicalTrials.gov ID
- NCT06170918
- Acronym / sponsor ID
- DRIP / XJH-A-20231120
- Conditions
- Anesthesia
- Keywords
- anesthesia induction, remimazolam, tracheal intubation, median effective dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 14 Dec 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, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl 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
- Model description
- The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg
| Arm | Type | Receives |
|---|---|---|
| remimazolam | Experimental | Drug: RemimazolamRemimazolam is given for anesthesia induction. The initial dosage is 0.4mg/kg, and the interval dosage is 0.02mg/kg. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age from 3 to 12 years old
- patients scheduled for surgery under general anesthesia
- Body mass index in the range of 5% -95% of the same age group
- Consent was obtained from the patient and the family members, and an informed consent form was signed
Key exclusion criteria (6 listed)
- American Society of Anesthesiologists status ≥3
- patients who cannot cooperate with intravenous anesthesia induction
- patients with risk of difficult airway
- patients who are allergic to benzodiazepines
- patients with neurological dysfunction
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 dose for intubation
Time frame: from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes
half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl
cardiovascular response to tracheal intubation
Time frame: from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes
cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation
2 secondary outcomes
the time to loss of consciousness
Time frame: from injection of remimazolam to loss of consciousness, at an average of 3 minutes
incidence of adverse events
Time frame: from injection of remimazolam to loss of consciousness, at an average of 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 36843931Fang YB, Wang CY, Gao YQ, Cai YH, Chen J, Zhang XL, Dong LQ, Shang-Guan WN, Liu HC. The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: Study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial. Front Pharmacol. 2023 Feb 10;14:1090608. doi: 10.3389/fphar.2023.1090608. eCollection 2023.
- Background: PubMed 37373624Kimoto Y, Hirano T, Kuratani N, Cavanaugh D, Mason KP. Remimazolam as an Adjunct to General Anesthesia in Children: Adverse Events and Outcomes in a Large Cohort of 418 Cases. J Clin Med. 2023 Jun 8;12(12):3930. doi: 10.3390/jcm12123930.
- 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.
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 4 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 Dec 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 dose for intubation (time frame: from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes). The study lists 2 primary outcomes in all. 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 NCT06170918, which also lists 2 linked publications.
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 Dec 2023.