Bidirectional Endoscopy
Conditions
Keywords
pediatric anesthesia, remimazolam, ED90
Brief summary
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.
Interventions
DRUGRemimazolam
Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
Sponsors
Tongji Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Age 0-12 years old, 2. ASA I-II level; 3. Sign an informed consent form.
Exclusion criteria
1. Developmental delay or neurological and psychiatric disorders; 2. Severe malnutrition or severe obesity; 3. High risk of stomach fullness and reflux aspiration; 4. Allergic to benzodiazepines and opioids; 5. Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours; 6. Severe sleep apnea; 7. Abnormal liver and kidney function; 8. Recently participated in other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Suppression Incidence | 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% |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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. |
| Time Records | The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening. | induction time |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 55 |
| 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 | 55 |
| Infant Group Age: \<48 months
Remimazolam: Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy | 10 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 45 |
Baseline characteristics
| Characteristic | 4-6 Years Group | 7-12 Years Group | Infant Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 55 Participants | 55 Participants | 10 Participants | 120 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6 years | 9 years | 3 years | 6 years |
| BMI | 15 kg/m2 STANDARD_DEVIATION 1.58 | 17 kg/m2 STANDARD_DEVIATION 2.49 | 15 kg/m2 STANDARD_DEVIATION 1.96 | 16 kg/m2 STANDARD_DEVIATION 2.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 55 Participants | 55 Participants | 10 Participants | 120 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 55 participants | 55 participants | 10 participants | 120 participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 3 Participants | 48 Participants |
| Sex: Female, Male Male | 32 Participants | 33 Participants | 7 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 | 0 / 10 |
| other Total, other adverse events | 0 / 55 | 0 / 55 | 0 / 10 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 | 0 / 10 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 4-6 Years Group | Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S | 0.674 units on a scale |
| 7-12 Years Group | Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S | 0.449 units on a scale |
| Infant Group | Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S | 0.937 units on a scale |
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.
Time frame: From the start of drug administration for induction to 24h after the operation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 4-6 Years Group | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 0 Participants |
| 7-12 Years Group | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 0 Participants |
| Infant Group | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 0 Participants |
Secondary
Respiratory Suppression Incidence
Respiratory frequency\<8 times/min or SP02\<90%
Time frame: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 4-6 Years Group | Respiratory Suppression Incidence | 4 Participants |
| 7-12 Years Group | Respiratory Suppression Incidence | 7 Participants |
| Infant Group | Respiratory Suppression Incidence | 2 Participants |
Secondary
Time Records
induction time
Time frame: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 4-6 Years Group | Time Records | 120 seconds |
| 7-12 Years Group | Time Records | 100 seconds |
| Infant Group | Time Records | 150 seconds |