Trial Outcomes & Findings for ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children (NCT NCT06121609)
NCT ID: NCT06121609
Last Updated: 2025-12-02
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
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
|
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
|
Infant Group
Age: \<48 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
45
|
Reasons for withdrawal
| Measure |
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
|
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
|
Infant Group
Age: \<48 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
45
|
Baseline Characteristics
ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children
Baseline characteristics by cohort
| Measure |
4-6 Years Group
n=55 Participants
Age: ≥48 and \<84 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
7-12 Years Group
n=55 Participants
Age: ≥84and \<156 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
Infant Group
n=10 Participants
Age: \<48 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
55 Participants
n=121 Participants
|
55 Participants
n=122 Participants
|
10 Participants
n=243 Participants
|
120 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
6 years
n=121 Participants
|
9 years
n=122 Participants
|
3 years
n=243 Participants
|
6 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=121 Participants
|
22 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
48 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=121 Participants
|
33 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
72 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
55 Participants
n=121 Participants
|
55 Participants
n=122 Participants
|
10 Participants
n=243 Participants
|
120 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
China
|
55 participants
n=121 Participants
|
55 participants
n=122 Participants
|
10 participants
n=243 Participants
|
120 participants
n=24 Participants
|
|
BMI
|
15 kg/m2
STANDARD_DEVIATION 1.58 • n=121 Participants
|
17 kg/m2
STANDARD_DEVIATION 2.49 • n=122 Participants
|
15 kg/m2
STANDARD_DEVIATION 1.96 • n=243 Participants
|
16 kg/m2
STANDARD_DEVIATION 2.12 • n=24 Participants
|
PRIMARY outcome
Timeframe: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.Population: The infant group was terminated prematurely due to the unknown safety dose boundary.
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
Outcome measures
| Measure |
4-6 Years Group
n=55 Participants
Age: ≥48 and \<84 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
7-12 Years Group
n=55 Participants
Age: ≥84and \<156 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
Infant Group
n=10 Participants
Age: \<48 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
|---|---|---|---|
|
Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S
|
0.674 units on a scale
Interval 0.66 to 0.76
|
0.449 units on a scale
Interval 0.423 to 0.59
|
0.937 units on a scale
Interval 0.65 to 1.264
|
SECONDARY outcome
Timeframe: 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%
Outcome measures
| Measure |
4-6 Years Group
n=55 Participants
Age: ≥48 and \<84 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
7-12 Years Group
n=55 Participants
Age: ≥84and \<156 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
Infant Group
n=10 Participants
Age: \<48 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
|---|---|---|---|
|
Respiratory Suppression Incidence
|
4 Participants
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
4-6 Years Group
n=55 Participants
Age: ≥48 and \<84 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
7-12 Years Group
n=55 Participants
Age: ≥84and \<156 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
Infant Group
n=10 Participants
Age: \<48 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.induction time
Outcome measures
| Measure |
4-6 Years Group
n=55 Participants
Age: ≥48 and \<84 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
7-12 Years Group
n=55 Participants
Age: ≥84and \<156 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
Infant Group
n=10 Participants
Age: \<48 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
|
|---|---|---|---|
|
Time Records
|
120 seconds
Interval 80.0 to 140.0
|
100 seconds
Interval 80.0 to 120.0
|
150 seconds
Interval 125.0 to 175.0
|
Adverse Events
4-6 Years Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
7-12 Years Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Infant Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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
Phone: +8618627784217
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place