Back to resultsEfficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Primary Purpose
Hypoxia, Gastric Cancer, Sedation Complication
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remimazolam tosylate
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia focused on measuring Hypoxia, Efficacy and Safety, Gastroscope, Remimazolam, Propofol
Eligibility Criteria
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:
- 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.).
Sites / Locations
- Renji HospitalRecruiting
- Shanghai East HospitalRecruiting
- Affiliated Hospital of Jiaxing UniversityRecruiting
- The Second Affifiliated Hospital of Jiaxing UniversityRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group
Test group 1（Remimazolam tosylate 0.15mg/kg）
Test group 2（Remimazolam tosylate 0.2mg/kg）
Arm Description
Propofol（1.5mg/kg）
Remimazolam tosylate 0.15mg/kg
Remimazolam tosylate 0.2mg/kg
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Sedation induction time
induction time
Sedation recovery time
recovery time
Incidence of drug injection pain
drug injection pain
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.
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
The incidence of hypoxia during sedation
(75% ≤ SpO2 < 90% for <60 s)；(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)
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.
Full Information
NCT ID
NCT04727034
First Posted
January 14, 2021
Last Updated
October 7, 2022
Sponsor
RenJi Hospital
Collaborators
Shanghai East Hospital, Affiliated Hospital of Jiaxing University, The Second Affifiliated Hospital of Jiaxing University, The First Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT04727034
Brief Title
Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Official Title
A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai East Hospital, Affiliated Hospital of Jiaxing University, The Second Affifiliated Hospital of Jiaxing University, The First Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Gastric Cancer, Sedation Complication, Propofol Adverse Reaction
Keywords
Hypoxia, Efficacy and Safety, Gastroscope, Remimazolam, Propofol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Propofol（1.5mg/kg）
Arm Title
Test group 1（Remimazolam tosylate 0.15mg/kg）
Arm Type
Experimental
Arm Description
Remimazolam tosylate 0.15mg/kg
Arm Title
Test group 2（Remimazolam tosylate 0.2mg/kg）
Arm Type
Experimental
Arm Description
Remimazolam tosylate 0.2mg/kg
Intervention Type
Drug
Intervention Name(s)
Remimazolam tosylate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment
Description
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
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary Outcome Measure Information:
Title
Sedation induction time
Description
induction time
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
Sedation recovery time
Description
recovery time
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
Incidence of drug injection pain
Description
drug injection pain
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
Doctor satisfaction and patient satisfaction
Description
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.
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
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;
Description
Sedation/Anaesthesia Discharge Rating Scale
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
The incidence of hypoxia during sedation
Description
(75% ≤ SpO2 < 90% for <60 s)；(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
Other adverse events assessed by the World SIVA adverse sedation event reporting tool
Description
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.
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huichen zhu, M.S.
Phone
+862168383702
Email
diansansu@yahoo.com
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai, China
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai, China
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangrui D Wang, Dr.
Phone
13701901953
Facility Name
Affiliated Hospital of Jiaxing University
City
Jiaxing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Yao, PhD
Phone
13758394990
Email
jxyaoming@163.com
Facility Name
The Second Affifiliated Hospital of Jiaxing University
City
Jiaxing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongmei zhou
Phone
13867300139
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shibiao chen
Phone
13870892918
Email
chenlaoshi1111@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
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