ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

T

Tongji Hospital

Status and phase

Enrolling
Phase 4

Conditions

Bidirectional Endoscopy

Treatments

Drug: Remimazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT06121609
EDRC

Details and patient eligibility

About

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

Full description

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.

Enrollment

165 estimated patients

Sex

All

Ages

Under 12 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

165 participants in 3 patient groups

0-3 years group
Experimental group
Description:
Age:<48 months
Treatment:
Drug: Remimazolam
4-6 years group
Experimental group
Description:
Age: ≥48 and <84 months
Treatment:
Drug: Remimazolam
7-12 years group
Experimental group
Description:
Age: ≥84and <156 months
Treatment:
Drug: Remimazolam

Trial contacts and locations

1

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Central trial contact

mujun Chang, Dr.; aihua Du

Data sourced from clinicaltrials.gov

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