Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-6 years group | Experimental | Age: ≥48 and <84 months |
|
| 7-12 years group | Experimental | Age: ≥84and <156 months |
|
| infant group | Experimental | Age: <48 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
|
| 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. |
| 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] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| aihua Du, Dr. | Tongji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41342333 | Derived | 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. |
Not provided
Not provided
You can request it from the main researcher.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 4-6 Years Group | Age: ≥48 and <84 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
| FG001 | 7-12 Years Group | Age: ≥84and <156 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
| FG002 | Infant Group | Age: <48 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The infant group was terminated early due to unknown safety dose boundaries.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 4-6 Years Group | Age: ≥48 and <84 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
| BG001 | 7-12 Years Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 infant group was terminated prematurely due to the unknown safety dose boundary. | Posted | Mean | 90% Confidence Interval | units on a scale | The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening. |
|
3days
The infant group was terminated prematurely due to the unknown safety dose boundary.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4-6 Years Group | Age: ≥48 and <84 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| aijun xu | 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 | +8618627784217 | ajxu@tjh.tjmu.edu.cn |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2024 | Aug 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2024 | Sep 22, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| C522201 | remimazolam |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
Age: ≥84and <156 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
| BG002 | Infant Group | Age: <48 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG001 | 7-12 Years Group | Age: ≥84and <156 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
| OG002 | Infant Group | Age: <48 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy |
|
|
| Secondary | Respiratory Suppression Incidence | Respiratory frequency<8 times/min or SP02<90% | Posted | Count of Participants | Participants | The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | From the start of drug administration for induction to 24h after the operation. |
|
|
|
| Secondary | Time Records | induction time | Posted | Median | Inter-Quartile Range | seconds | The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening. |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | 7-12 Years Group | Age: ≥84and <156 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy | 0 | 55 | 0 | 55 | 0 | 55 |
| EG002 | Infant Group | Age: <48 months Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided