The Application of Remazolam in Gastroenteroscopy

Gastroenterology Clinical Trial

Official title:

The Application of Remazolam in Gastroenteroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357430
• Other study ID #: 2020-YKL12-23
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: April 2, 2023

Study information

• Verified date: April 2022
• Source: Yangzhou University
• Contact: Chen Jin, student
• Phone: 18752145706
• Email: 862387297[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OBJECTIVE: To study the safety, efficacy and clinical significance of remimazolam in the diagnosis and treatment of elderly obese patients with daytime gastrointestinal endoscopy, calculate the optimal dose, and conduct relevant verification. Provide a safer and more effective anesthesia solution for the growing special population.

METHODS：Around 160 patients were selected to receive painless gastroenteroscopy.，they were divided into four groups of D1, D2, R and C. Group D1 and D2(including 60 patients) were used to calculate the ED50 and ED95 of the drug. According to up-and-down method, they were slowly injected 0.3μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤３. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg. And the study was terminated when seven crossing points occurred. One hundred patients were randomly divided into two groups of R and C.Before administration of remimazolam, remifentanil injection 0.3 μg/kg were given intravenously in two groups, respectively (injection rate was 30 s).Then group R was given the calculated dose of remimazolam, and group C was given propofol 1.5-2mg/kg.The success rate of sedation, changes in vital signs, adverse reactions, and postoperative recovery were recorded in the two groups.

Description:

The study used up-and-down methods to calculate the ED50 and ED95. According to up-and-down method, group D1 and D2 were slowly injected 0.5μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤３. The standard for a positive response in patients undergoing gastroscopy: coughing, swallowing, frowning, and physical movement affecting the operation during the examination. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg.And the study was terminated when seven crossing points occurred. Probit regression analysis method was used to calculate the ED50, ED95 and 95%CI of remimazolam combined with remifentanil in painless gastroenteroscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 2, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 18-85 years old; ASA classification I-II grade

Exclusion Criteria:

• Asthma; allergic to the drugs involved and contraindicated; patients with severe respiratory system, cardiovascular system diseases and coagulation insufficiency of liver and kidney function; patients with severe neuropsychiatric system diseases

Related Conditions & MeSH terms

• Gastroenterology

Intervention

Drug:
• Remimazolam
0.3µg/kg of remifentanil was injected slowly in advance, then different doses of Remimazolam was injected to two groups of D1 and D2, according to up-and-down method.
• Remimazolam
0.3µg/kg of remifentanil was injected slowly in advance, then the calculated dose from groups of D1 and D2 of remimazolam was injected to group R.
• Propofol
0.3µg/kg of remifentanil was injected slowly in advance, then 1.5-2mg/kg of Propofol was injected to group C

Locations

Country	Name	City	State
China	Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of sedation	After the administration of remimazolam, observe and record the response	1-3minutes
Primary	Blood pressure value	record the blood pressure before and after administration	1-30minutes
Primary	Heart rate	record the heart rate before and after administration	1-30minutes
Secondary	Incidence of adverse reactions	Incidence of adverse reactions such as intraoperative movement, choking, respiratory depression, hiccups, nausea and vomiting, dizziness, laryngospasm	1-30minutes