Bidirectional EndoscopyED90NCT06121609
ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children
A study testing Remimazolam in people with Bidirectional Endoscopy, run by Tongji Hospital at 1 site in China.
Trial summary
Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Bidirectional Endoscopy
- What is being tested?
- Remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-12 years old,
- ASA I-II level;
- Sign an informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bidirectional Endoscopy
- Being tested
- Remimazolam
- Keywords
- pediatric anesthesia, remimazolam, ED90
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Remimazolam besylate
Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
| Study group | Role | What they receive |
|---|---|---|
| 4-6 years group | Experimental | Age: ≥48 and <84 months Receives: Drug: Remimazolam |
| 7-12 years group | Experimental | Age: ≥84and <156 months Receives: Drug: Remimazolam |
| infant group | Experimental | Age: <48 months Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.
Secondary outcomes (3)
Respiratory Suppression Incidence
Respiratory frequency<8 times/min or SP02<90%
Measured: 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.
Measured: From the start of drug administration for induction to 24h after the operation.
Time Records
induction time
Measured: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start15 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bidirectional EndoscopyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- aihua Du, Dr., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121609
- Sponsor's protocol ID
- EDRC
- Acronym
- ED90
- Status last verified
- Nov 2025
- First submitted
- 25 Oct 2023
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: You can request it from the main researcher.
Publications
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. 2026 May;92(5):1417-1426. doi: 10.1002/bcp.70406. Epub 2025 Dec 4.
PubMed 41342333
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children: a Biased Coin up and Down Sequential Trial
- ClinicalTrials.gov ID
- NCT06121609
- Acronym / sponsor ID
- ED90 / EDRC
- Conditions
- Bidirectional Endoscopy
- Keywords
- pediatric anesthesia, remimazolam, ED90
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-6 years group | Experimental | Drug: RemimazolamAge: ≥48 and <84 months |
| 7-12 years group | Experimental | Drug: RemimazolamAge: ≥84and <156 months |
| infant group | Experimental | Drug: RemimazolamAge: <48 months |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 0-12 years old,
- ASA I-II level;
- Sign an informed consent form.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamAlso: Remimazolam besylateExploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy | Drug | 4-6 years group, 7-12 years group, infant group |
Primary outcome
Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S
Time frame: 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
3 secondary outcomes
Respiratory Suppression Incidence
Time frame: 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]
Time frame: From the start of drug administration for induction to 24h after the operation.
Time Records
Time frame: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41342333Zhou 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. 2026 May;92(5):1417-1426. doi: 10.1002/bcp.70406. Epub 2025 Dec 4.
- Individual participant dataSharing planned: No. You can request it from the main researcher.
Related trials for Bidirectional Endoscopy
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Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients
Elderly Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
aihua Du, Dr. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam in people with Bidirectional Endoscopy, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S (time frame: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.