Dose of Remimazolam in Children for Intubation

NCT ID: NCT06170918

Last Updated: 2023-12-14

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia

Keywords

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anesthesia induction remimazolam tracheal intubation median effective dose

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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remimazolam

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

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
* 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

Exclusion Criteria

* 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
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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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.

Reference Type BACKGROUND
PMID: 36843931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37373624 (View on PubMed)

Other Identifiers

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XJH-A-20231120

Identifier Type: -

Identifier Source: org_study_id