Effective Dose of Remimazolam Combined With Propofol in Painless Gastroscopy

Effect of Drug Clinical Trial

Official title:

Effective Dose of Remiazolam Tosylate Combined With Propofol in Upper Gastrointestinal Endoscopy Sedation: a Dose-determination Study Using Dixon's Up-and-down Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05876793
• Other study ID #: HR7056+propofol
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Sichuan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study used sequential method（Dixon's up and douwn） to determine the effective dose of remiazolam combined with propofol in painless upper gastrointestinal endoscopy

Description:

Remimazolam tosylate is a novel benzodiazepine drug that can be used for gastrointestinal sedation. However, some studies have reported that the sedative effect of using remimazolam alone is poor, and the patient's body movements are obvious, which affects the operation of endoscopists. Propofol, as a commonly used sedative drug, has good sedative effects, but has a high incidence of adverse events, especially cardiovascular system inhibition. Therefore, this study will explore the effective dose of remimazolam combined with propofol, reduce the adverse events of propofol and increase the sedative efficacy of remimazolam. This study only set up one study group, fixed the dosage of propofol, adjusted the dosage of Remimazolam to meet the appropriate sedation requirements for patients. Patients with successful sedation were judged to have a negative reaction, while patients with failed sedation were judged to have a positive reaction. A sequential chart was drawn based on the sedation situation until 7 positive negative reaction intersections were found, and the study ended

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA grading I to II, with a BMI of 18 to 30 kg/m2

Exclusion Criteria:

• Uncontrolled severe hypertension, previous history of abnormal anesthesia, unstable angina and myocardial infarction, abnormal liver and kidney function, acute upper respiratory tract infection, suspected difficulty in the airways, allergies to opioids, milk, eggs, and propofol, long-term use of sedative and analgesic drugs.

Related Conditions & MeSH terms

• Effect of Drug

Intervention

Drug:
• Remimazolam tosilate
The fixed dose of propofol in this study was 0.5mg/kg, with an injection time of 30 seconds. Subsequently, remimazolam was administered at an initial dose of 0.1mg/kg. After 1 minute of administration, sedation was evaluated using MOAA/S. When the MOAA/S score was = 1, endoscopic examination could begin. If the patient did not show physical activity or coughing, sedation was considered successful, and the next patient's medication dose was reduced by 0.02mg/kg; On the contrary, if sedation fails, the next patient will receive an additional 0.02mg/kg of medication.Successful sedation results in a positive reaction, while failure results in a negative reaction. This study ends when 7 positive and negative reactions intersect

Locations

Country	Name	City	State
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of body movements or coughing	Incidence of body movements or coughing=(Number of people experiencing physical activity or coughing/total number of people studied)	Day 1
Secondary	Sedation success time	MOAA/S=1	Day 1
Secondary	Inspection time	The time from the beginning of the endoscopy to the exit of the examination mirror from the oral cavity	Day 1
Secondary	full alert time	The time from the last administration to the first MOAA/S score of 5 points when the patient reaches 5 points in three consecutive MOAA/S scores	Day 1
Secondary	incidence of adverse events	Mainly including respiratory adverse events and circulatory adverse events	Day 1