ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children (ED90)

The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children: a Biased Coin up and Down Sequential Trial

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

Study Overview

• Status: Completed
• Conditions: Bidirectional Endoscopy
• Intervention / Treatment: Drug: Remimazolam

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-6 years group; Age: ≥48 and <84 months	Drug: Remimazolam; Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy; Other Names: Remimazolam besylate
Experimental: 7-12 years group; Age: ≥84and <156 months	Drug: Remimazolam; Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy; Other Names: Remimazolam besylate
Experimental: infant group; Age: <48 months	Drug: Remimazolam; Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy; Other Names: Remimazolam besylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S	Using the modified MOAA/S scoring table（ranging from 5-0） to evaluate if the sedation is successful. 5 points：Respond quickly to names spoken in a normal tone 4 points：Showing a drowsy reaction to names spoken in a normal tone 3 points：Only react after loudly and/or repeatedly calling the name 2 points：Response immediately after slight stimulation or shaking 1point：Response only occurs after compression of the trapezius muscle that causes pain 0 point：No response after compression of the trapezius muscle	The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Suppression Incidence	Respiratory frequency<8 times/min or SP02<90%	The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc.	From the start of drug administration for induction to 24h after the operation.
Time Records	induction time	The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: aihua Du, Dr., Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pediatric anesthesia; remimazolam; ED90
• Additional Relevant MeSH Terms: remimazolam
• Other Study ID Numbers: EDRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: You can request it from the main researcher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No