ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

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