Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Gastric Cancer; Sedation Complication; Propofol Adverse Reaction
• Intervention / Treatment: Drug: Propofol; Drug: Remimazolam tosylate

• Study Type: Interventional
• Enrollment (Anticipated): 1800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huichen zhu, M.S.; Phone Number: +862168383702; Email: diansansu@yahoo.com

Study Locations

• China
  • Jiaxing, China
    • Recruiting
    • Affiliated Hospital of Jiaxing University
    • Contact: Ming Yao, PhD; Phone Number: 13758394990; Email: jxyaoming@163.com
  • Jiaxing, China
    • Recruiting
    • The Second Affifiliated Hospital of Jiaxing University
    • Contact: Hongmei zhou; Phone Number: 13867300139
  • Nanchang, China
    • Recruiting
    • The First Affiliated Hospital of NanChang University
    • Contact: shibiao chen; Phone Number: 13870892918; Email: chenlaoshi1111@163.com
  • Shanghai, China
    • Shanghai, Shanghai, China, China, 200127
      • Recruiting
      • Renji Hospital
    • Shanghai, Shanghai, China, China, 200127
      • Recruiting
      • Shanghai East Hospital
      • Contact: Xiangrui D Wang, Dr.; Phone Number: 13701901953

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 1)18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2<BMI<28kg/m2； 5) It is estimated that the operation time of gastroscope will not exceed 30 minutes; 6) Clearly understand, voluntarily participate in the research, and be signed and informed consent.

Exclusion Criteria:

1. Need to perform complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography Surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa Stripping, oral endoscopic muscle dissection, etc.);
2. Patients who intend to undergo tracheal intubation;
3. It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient;
4. Anemia or thrombocytopenia,( Hb<90g/L, PLT<80×109/L);
5. Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer);
6. Liver and kidney disease;( AST and/or ALT≥2.5×ULN,TBIL≥1.5×ULN, blood creatinine is greater than the upper limit of normal);
7. There is a history of drug and/or alcohol abuse within 2 years before the beginning of the screening period.The average daily alcohol consumption exceeds 2 units of alcohol (1 unit = 360 mL beer Liquor or 45 mL liquor with 40% alcohol content or 150 mL grapes liqueur);
8. Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs(Sitting systolic blood pressure ≥160 mmHg during screening period, and/or diastolic pressure during screening period Pressure ≥100 mmHg);
9. Sitting systolic blood pressure ≤90 mmHg during the screening period;
10. Women who are pregnant or breastfeeding;
11. Benzodiazepines, opioids, propofol, lidoca Those who are allergic or contraindicated due to their drug components;
12. Participated in other drug clinical trials as subjects in the past 3 months;
13. The investigator believes that it is not appropriate to participate in this trial;
14. A well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group; Propofol（1.5mg/kg）	Drug: Propofol; Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high.
EXPERIMENTAL: Test group 1（Remimazolam tosylate 0.15mg/kg）; Remimazolam tosylate 0.15mg/kg	Drug: Remimazolam tosylate; Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
EXPERIMENTAL: Test group 2（Remimazolam tosylate 0.2mg/kg）; Remimazolam tosylate 0.2mg/kg	Drug: Remimazolam tosylate; Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment	1) Complete the entire process of gastroscopy; 2) No sedative remedy is given; 3) After the initial dose of the test drug is administered, additional administration ≤ 2 times within any 5-minute period; 4) The initial dose of propofol After the end, within any 5-minute period of additional administration ≤ 2 times, it is recorded as propofol (control group) successfully sedated	Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation induction time	induction time	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Sedation recovery time	recovery time	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of drug injection pain	drug injection pain	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Doctor satisfaction and patient satisfaction	There is a scale from 1 to 10. Endoscopists and patients will score their satisfaction with the scale ,with 1-3 (dissatisfied),4-6 (satisfied) and 7-10 (very satisfied) after gastroscopy.	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The time it takes for the patient to wake up and leave the hospital if the Sedation/Anaesthesia Discharge Rating Scale score exceeds 9 points;	Sedation/Anaesthesia Discharge Rating Scale	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of hypoxia during sedation	(75% ≤ SpO2 < 90% for <60 s)；(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events assessed by the World SIVA adverse sedation event reporting tool	other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.	Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; Shanghai East Hospital; Affiliated Hospital of Jiaxing University; The Second Affifiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2021
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (ACTUAL): January 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Efficacy and Safety; Hypoxia; Propofol; Remimazolam; Gastroscope
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: sudiansan1215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No