The Application of Remazolam in Gastroenteroscopy

Not Applicable

Completed

• Conditions: Gastroenterology
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT05357430
• Lead Sponsor: Yangzhou University

Brief Summary

OBJECTIVE: To study the safety, efficacy and clinical significance of remimazolam in the diagnosis and treatment of 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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Primary Completion: 2023-04-01
• Study Completion: 2023-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Age 18-65 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group D1(males)	Remimazolam	Administration of 0.3μg/kg of remifentanil in advance, then corresponding dose of remimazolam, according to the experimental results of the previous patient.
group C	Propofol	Administration of 0.3μg/kg of remifentanil in advance, then 1.5-2mg/kg propofol.
group D2(females)	Remimazolam	Administration of 0.3μg/kg of remifentanil in advance, then corresponding dose of remimazolam, according to the experimental results of the previous patient.
group R	Remimazolam	Administration of 0.3μg/kg of remifentanil in advance, then the calculated dose of remimazolam, according to the experimental results of the previous patient.

Primary Outcome Measures

Name	Time	Method
Success rate of sedation	1-3minutes	After the administration of remimazolam, observe and record the response
Blood pressure value	1-30minutes	record the blood pressure before and after administration
Heart rate	1-30minutes	record the heart rate before and after administration

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse reactions	1-30minutes	Incidence of adverse reactions such as intraoperative movement, choking, respiratory depression, hiccups, nausea and vomiting, dizziness, laryngospasm

Trial Locations

Locations (1)

Affiliated Hospital of Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China