ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

Bidirectional Endoscopy Clinical Trial

— ED90  

Official title:

The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children: a Biased Coin up and Down Sequential Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121609
• Other study ID #: EDRC
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Tongji Hospital
• Contact: mujun Chang, Dr.
• Phone: +862783663625
• Email: changmujun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bidirectional Endoscopy

Intervention

Drug:
• Remimazolam
Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

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