ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

NCT06121609 | Completed Results

• 1 other identifier: EDRC
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bidirectional Endoscopy

Keywords

pediatric anesthesia; remimazolam; ED90

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Respiratory Suppression Incidence

  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]

  From the start of drug administration for induction to 24h after the operation.

• Time Records

  The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.

Study Arms (3)

4-6 years group

EXPERIMENTAL

Age: ≥48 and \<84 months

Drug: Remimazolam

7-12 years group

EXPERIMENTAL

Age: ≥84and \<156 months

Drug: Remimazolam

infant group

EXPERIMENTAL

Age: \<48 months

Drug: Remimazolam

Interventions

Remimazolam DRUG

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

Also known as: Remimazolam besylate

4-6 years group; 7-12 years group; infant group

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Related Publications (1)

• Zhou SQ, Bi Y, Chu TT, Tian Z, Yu SC, Yan TQ, Deng JB, Xu AJ. Effective remimazolam induction dose in paediatric same-day bidirectional endoscopy: A biased coin up and down sequential trial. Br J Clin Pharmacol. 2025 Dec 4. doi: 10.1002/bcp.70406. Online ahead of print.

  PMID: 41342333 DERIVED

MeSH Terms

Interventions

remimazolam

Results Point of Contact

• Title: aijun xu
• Organization: Department of Anesthesiology and Pain Medicine, Hubei Key Laboratory of Geriatric Anesthesia and Perioperative Brain Health, and Wuhan Clinical Research Center for Geriatric Anesthesia, Tongji Hospital, Tongji Medical College, Huazhong University of Scien

ajxu@tjh.tjmu.edu.cn

+8618627784217

Study Officials

• aihua Du, Dr.

  Tongji Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 8, 2023
• Study Start: January 15, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)