Bidirectional Endoscopy Clinical Trial
— ED90Official 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.
Status | Recruiting |
Enrollment | 165 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 12 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 |
1 day | |
Secondary | Respiratory suppression incidence | Respiratory frequency<8 times/min or SP02<90% | 1 day | |
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. | 2 days | |
Secondary | Time records | Anesthesia time, induction time, surgical time, awakening time, and recovery time; | 1 day | |
Secondary | Use of drugs | The total amount of sedative and analgesic drugs used. | 1 day | |
Secondary | Postoperative pain assessment | 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. | 2 days | |
Secondary | Baxter Retching Faces (BARF) nausea scale | 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. |
2 days | |
Secondary | Sleep quality. | The sleep quality was assessed with a 3-point scale: 0=slept well, 1=woke up crying in the night, and 2=intermittent sleep. | 2 days | |
Secondary | Daily activities | 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. | 2 days | |
Secondary | Parental satisfaction | 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. | 2 days |
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