ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

Not Applicable

Completed

• Conditions: Bidirectional Endoscopy
• Interventions: Drug: Remimazolam

• Registration Number: NCT06121609
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Study Start: 2024-01-15
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
7-12 years group	Remimazolam	Age: ≥84and \<156 months
4-6 years group	Remimazolam	Age: ≥48 and \<84 months
0-3 years group	Remimazolam	Age:\<48 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Use of drugs	1 day	The total amount of sedative and analgesic drugs used.
Time records	1 day	Anesthesia time, induction time, surgical time, awakening time, and recovery time;
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China