Effective Dose of Remimazolam Combined With Propofol in Painless Gastroscopy

NCT05876793 | Completed

• 1 other identifier: HR7056+propofol
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Effect of Drug

Keywords

combination; effective dose; remimazolam; propofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sedation success time

  Day 1

• Inspection time

  Day 1

• full alert time

  Day 1

• incidence of adverse events

  Day 1

Study Arms (1)

remimazolam tosylate

EXPERIMENTAL

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

Interventions

Remimazolam tosilate DRUG

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

remimazolam tosylate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: We will use the Dixon's up and down method.

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 25, 2023
• Study Start: June 1, 2023
• Primary Completion: June 12, 2023
• Study Completion: June 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)