ClinicalTrials.gg
Not yet recruitingNCT06170918DRIPUpdated Dec 14, 2023

Dose of Remimazolam in Children for Intubation

An interventional study of Remimazolam in Anesthesia, sponsored by Zhihong LU. Not yet recruiting. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Zhihong LU · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
3 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia

Keywords

  • anesthesia induction
  • remimazolam
  • tracheal intubation
  • median effective dose
03

In context

Lead sponsor

Zhihong LU is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age from 3 to 12 years old
  • patients scheduled for surgery under general anesthesia
  • in the range of 5% -95% of the same age group
  • Consent was obtained from the patient and the family members, and an form was signed

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    remimazolam

    Remimazolam is given for anesthesia induction. The initial dosage is 0.4mg/kg, and the interval dosage is 0.02mg/kg.

    Drug: Remimazolam

Interventions

  • remimazolam is given intravenously

    Also known as: remimazolam besylate

06

What researchers measure

Primary outcomes

  1. half effective dose for intubation

    half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl

    Time frame: from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes

  2. 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

    Time frame: from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes

Secondary outcomes

  1. the time to loss of consciousness

    Time frame: from injection of remimazolam to loss of consciousness, at an average of 3 minutes

  2. incidence of adverse events

    adverse events include bradycardia, hypotension, hypoxemia, and injection pain

    Time frame: from injection of remimazolam to loss of consciousness, at an average of 3 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

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 36843931 ↗
  • Kimoto 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2023; primary completion for May 2024, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2023
First posted
Dec 14, 2023
StartEst.
Dec 20, 2023
Primary completionEst.
May 31, 2024
CompletionEst.
May 31, 2024
Last update
Dec 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06170918
Lead sponsor
Zhihong LU
Responsible party
Zhihong LU (Associate professor, Air Force Military Medical University, China) — Sponsor-investigator
First posted
Dec 14, 2023
Start date
Dec 20, 2023 (estimated)
Primary completion
May 31, 2024 (estimated)
Completion
May 31, 2024 (estimated)
Last update
Dec 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Remimazolam

Start the discussion