ClinicalTrials.gg
Not yet recruitingNCT05990673DRINKUpdated Aug 14, 2023

Dose of Remi in Children

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 2023-08-14.

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

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
25
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, the effective dosage of remimazolam in pediatric patients is still unknown.

02

Conditions studied

  • Anesthesia

Keywords

  • general anesthesia
  • anesthesia induction
  • remimazolam
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

Exclusion criteria

Exclusion Criteria:

  • status >=Ⅲ
  • >=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
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

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

Study arms

  • Experimental
    remimazolam

    remimazolam is given for anesthesia induction

    Drug: Remimazolam

Interventions

  • remimazolam is given intravenously

    Also known as: remimazolam besylate

06

What researchers measure

Primary outcomes

  1. half effective dosage

    the dosage by which half of the patients will be sedated

    Time frame: 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

    Time frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 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
NCT05990673
Lead sponsor
Zhihong LU
Responsible party
Zhihong LU (Associate professor, Air Force Military Medical University, China) — Sponsor-investigator
First posted
Aug 14, 2023
Start date
Aug 10, 2023 (estimated)
Primary completion
Sep 10, 2023 (estimated)
Completion
Sep 10, 2023 (estimated)
Last update
Aug 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 Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Remimazolam

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