ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children (ED90)

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.

Study Overview

• Status: Recruiting
• Conditions: Bidirectional Endoscopy
• Intervention / Treatment: Drug: Remimazolam

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 Type: Interventional
• Enrollment (Estimated): 165
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: mujun Chang, Dr.; Phone Number: +862783663625; Email: changmujun@hotmail.com
• Study Contact Backup: Name: aihua Du; Phone Number: +862783663625; Email: tongjihlunli@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tongji Hospital
      • Contact: aijun xu, Dr.; Phone Number: 027-83663173; Email: ajxu@tjh.tjmu.edu.cn
      • Contact: Siqi Zhou, Dr.; Phone Number: 027-15151271698; Email: 376308761@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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; Other Names: Remimazolam besylate
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: Remimazolam besylate
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: Remimazolam besylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory suppression incidence	Respiratory frequency<8 times/min or SP02<90%	1 day
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
Time records	Anesthesia time, induction time, surgical time, awakening time, and recovery time;	1 day
Use of drugs	The total amount of sedative and analgesic drugs used.	1 day
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: aihua Du, Dr., Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pediatric anesthesia; remimazolam; ED90
• Other Study ID Numbers: EDRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: You can request it from the main researcher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No