NCT06121609: ED90

ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

Completed NA Results posted Last updated 2 December 2025

What this trial tests

NA trial testing Remimazolam in Bidirectional Endoscopy in 165 participants. Completed in 30 April 2024.

Timeline

15 January 2024

Primary endpoint
30 April 2024

30 April 2024

Quick facts

Lead sponsor	Tongji Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	165
Start date	15 January 2024
Primary completion	30 April 2024
Estimated completion	30 April 2024
Sites	1 location across China

Drugs / interventions tested

• Remimazolam — full drug profile →

Conditions studied

• Bidirectional Endoscopy — all drugs for Bidirectional Endoscopy →

Sponsor

Tongji Hospital

Who can join

Under 12, any sex, with Bidirectional Endoscopy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S Primary · The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.

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

Group	Value	95% CI
4-6 Years Group	0.674	0.66 – 0.76
7-12 Years Group	0.449	0.423 – 0.59
Infant Group	0.937	0.65 – 1.264

Respiratory Suppression Incidence Secondary · The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.

Respiratory frequency\<8 times/min or SP02\<90%

Group	Value	95% CI
4-6 Years Group	4
7-12 Years Group	7
Infant Group	2

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Secondary · From the start of drug administration for induction to 24h after the operation.

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.

Group	Value	95% CI
4-6 Years Group	0
7-12 Years Group	0
Infant Group	0

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

induction time

Group	Value	95% CI
4-6 Years Group	120	80 – 140
7-12 Years Group	100	80 – 120
Infant Group	150	125 – 175

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remimazolam as a Novel Anesthetic in Pediatric Procedural Sedation and Anesthesia: A Narrative Review.
   Zhu M, Tang M. · · 2025 · cited 1× · PMID 40688881 · DOI 10.7759/cureus.86354
2. Effective remimazolam induction dose in paediatric same-day bidirectional endoscopy: A biased coin up and down sequential trial.
   Zhou SQ, Bi Y, Chu TT, Tian Z, et al · · 2026 · PMID 41342333 · DOI 10.1002/bcp.70406