Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

NCT04727034 | Unknown

• 1 other identifier: sudiansan1215
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hypoxia; Gastric Cancer; Sedation Complication; Propofol Adverse Reaction

Keywords

Hypoxia; Efficacy and Safety; Gastroscope; Remimazolam; Propofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Sedation induction time

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Sedation recovery time

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Incidence of drug injection pain

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Doctor satisfaction and patient satisfaction

  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;

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Study Arms (3)

Control group

ACTIVE COMPARATOR

Propofol（1.5mg/kg）

Drug: Propofol

Test group 1（Remimazolam tosylate 0.15mg/kg）

EXPERIMENTAL

Remimazolam tosylate 0.15mg/kg

Drug: Remimazolam tosylate

Test group 2（Remimazolam tosylate 0.2mg/kg）

EXPERIMENTAL

Remimazolam tosylate 0.2mg/kg

Drug: Remimazolam tosylate

Interventions

Remimazolam tosylate DRUG

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.

Test group 1（Remimazolam tosylate 0.15mg/kg）; Test group 2（Remimazolam tosylate 0.2mg/kg）

Propofol DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.);
• Patients who intend to undergo tracheal intubation;
• It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient;
• Anemia or thrombocytopenia,( Hb\<90g/L, PLT\<80×109/L);
• Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer);
• 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);
• 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);
• 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);
• Sitting systolic blood pressure ≤90 mmHg during the screening period;
• Women who are pregnant or breastfeeding;
• Benzodiazepines, opioids, propofol, lidoca Those who are allergic or contraindicated due to their drug components;
• Participated in other drug clinical trials as subjects in the past 3 months;
• The investigator believes that it is not appropriate to participate in this trial;
• A well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai East Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• The Second Affifiliated Hospital of Jiaxing University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (5)

Renji Hospital

Shanghai, Shanghai, China, 200127, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai, China, 200127, China

RECRUITING

Affiliated Hospital of Jiaxing University

Jiaxing, China

RECRUITING

The Second Affifiliated Hospital of Jiaxing University

Jiaxing, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Related Publications (1)

• Zhu H, Su Z, Huai X, Chen C, Zhang X, Zhou J, Su D. Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 12;23(1):995. doi: 10.1186/s13063-022-06935-0.

  PMID: 36510290 DERIVED

MeSH Terms

Conditions

Hypoxia; Stomach Neoplasms

Interventions

4-methylbenzenesulfonic acid; Propofol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Diansan Su, Dr.

CONTACT

+862168383702; diansansu@yahoo.com

Huichen zhu, M.S.

CONTACT

+862168383702; diansansu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 27, 2021
• Study Start: March 2, 2021
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

CN (5)