ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-04-30

Brief Summary

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Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.

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Detailed Description

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Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups, providing a more scientific clinical dose selection basis for the anesthesia induction application of Remazolam.

Conditions

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Bidirectional Endoscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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4-6 years group

Age: ≥48 and \<84 months

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy

7-12 years group

Age: ≥84and \<156 months

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy

infant group

Age: \<48 months

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy

Interventions

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Remimazolam

Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy

Intervention Type DRUG

Other Intervention Names

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Remimazolam besylate

Eligibility Criteria

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Inclusion Criteria

1. Age 0-12 years old,
2. ASA I-II level;
3. Sign an informed consent form.

Exclusion Criteria

1. Developmental delay or neurological and psychiatric disorders;
2. Severe malnutrition or severe obesity;
3. High risk of stomach fullness and reflux aspiration;
4. Allergic to benzodiazepines and opioids;
5. Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
6. Severe sleep apnea;
7. Abnormal liver and kidney function;
8. Recently participated in other clinical studies.

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No