Effective Dose of Remimazolam Combined With Propofol in Painless Gastroscopy

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

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

Study Overview

• Status: Completed
• Conditions: Effect of Drug
• Intervention / Treatment: Drug: Remimazolam tosilate

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: remimazolam tosylate; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation success time	MOAA/S≤1	Day 1
Inspection time	The time from the beginning of the endoscopy to the exit of the examination mirror from the oral cavity	Day 1
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
incidence of adverse events	Mainly including respiratory adverse events and circulatory adverse events	Day 1

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: propofol; combination; remimazolam; effective dose
• Other Study ID Numbers: HR7056+propofol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No