ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children
Study Details
Study Description
Brief Summary
Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0-3 years group Age:<48 months |
Drug: Remimazolam
Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
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| Experimental: 4-6 years group Age: ≥48 and <84 months |
Drug: Remimazolam
Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
Other Names:
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| Experimental: 7-12 years group Age: ≥84and <156 months |
Drug: Remimazolam
Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy
Other Names:
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Outcome Measures
Primary Outcome Measures
- Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S [1 day]
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 Outcome Measures
- Respiratory suppression incidence [1 day]
Respiratory frequency<8 times/min or SP02<90%
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [2 days]
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 [1 day]
Anesthesia time, induction time, surgical time, awakening time, and recovery time;
- Use of drugs [1 day]
The total amount of sedative and analgesic drugs used.
- Postoperative pain assessment [2 days]
Assess the patient's FLACC score(ranging from 0-10) at different time points (0 minutes after awakening, 10 minutes after awakening) and within 24 hours after surgery on the PACU (Postanesthesia care unit); The Flacc score divides the degree of pain into five parts: facial expression, leg activity, posture, crying, and comfort level. Each part is divided into three parts: 0, 1, and 2. The higher the score, the higher the degree of pain. The total score of the last five parts is the Flacc score, which ranges from 0 to 10 points.
- Baxter Retching Faces (BARF) nausea scale [2 days]
Assess PONV until discharge with the use of the Baxter Retching Faces (BARF) nausea scale. The BARF scale is a visual scale that draws six scales based on children's nausea and vomiting based on their facial expressions, representing 0 points (no nausea and vomiting), 2 points and 4 points (mild nausea and vomiting), 6 points and 8 points (severe nausea and vomiting), and 10 points (vomiting), respectively.
- Sleep quality. [2 days]
The sleep quality was assessed with a 3-point scale: 0=slept well, 1=woke up crying in the night, and 2=intermittent sleep.
- Daily activities [2 days]
Daily activity was evaluated using the following 3-point scale: 0=normal quality,1=depressed but performed normal daily activities, and 2=irritable and could not perform normal activities.
- Parental satisfaction [2 days]
Parental satisfaction was assessed with the 11-point numeric rating scale (NRS) ranging from 0 to 10, whereby a score of 10 indicated the highest satisfaction.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 0-12 years old,
-
ASA I-II level;
-
Sign an informed consent form.
Exclusion Criteria:
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Developmental delay or neurological and psychiatric disorders;
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Severe malnutrition or severe obesity;
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High risk of stomach fullness and reflux aspiration;
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Allergic to benzodiazepines and opioids;
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Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
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Severe sleep apnea;
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Abnormal liver and kidney function;
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Recently participated in other clinical studies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tongji Hospital | Wuhan | Hubei | China | 430000 |
Sponsors and Collaborators
- Tongji Hospital
Investigators
- Study Chair: aihua Du, Dr., Tongji Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EDRC