Dose of Remi in Children

NCT ID: NCT05990673

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2023-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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remimazolam

remimazolam is given for anesthesia induction

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

remimazolam is given intravenously

Interventions

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Remimazolam

remimazolam is given intravenously

Intervention Type DRUG

Other Intervention Names

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remimazolam besylate

Eligibility Criteria

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Inclusion Criteria

* age from 3 to 12 years old
* patients scheduled for surgery under general anesthesia

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhihong LU

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 37333966 (View on PubMed)

Other Identifiers

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XJH-A-20230606

Identifier Type: -

Identifier Source: org_study_id

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