Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding
Primary Purpose
Endoscopic Hemostasis, Sedation
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Propofol
Remimazolam besylate
Sponsored by
About this trial
This is an interventional treatment trial for Endoscopic Hemostasis
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with bleeding from ruptured esophageal and gastric varices
- Endoscopic hemostatic treatment was performed
- Body Mass Index(BMI)18~28kg/m2
Exclusion Criteria:
- History or evidence of increased risk of sedation/anesthesia;
- Pregnant and lactating women;
- Have participated in other drug trials within 30 days prior to enrollment;
- those with contraindications to propofol, opioids and their remedies;
- Unwilling to sign informed consent.
Sites / Locations
- Renmin Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
propofol
Remimazolam besylate
Arm Description
The control group was sedated with propofol
The experimental group was given remazolam besylate for sedation
Outcomes
Primary Outcome Measures
Sedation scores
sedation scores were performed during administration,Richmond Agitation-Sedation Scale(RASS)1~-2 was defined as compliance,Otherwise, sedation was considered inadequate
Secondary Outcome Measures
Rate of adverse events
Any adverse events that occurred during the administration of the drug, such as bradycardia, hypotension, respiratory depression, etc
Vital signs
Systolic and Diastolic Blood Pressure
Full Information
NCT ID
NCT05554965
First Posted
September 15, 2022
Last Updated
November 7, 2022
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT05554965
Brief Title
Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding
Official Title
Clinical Study of Remazolam Besylate for Sedation During Endoscopic Hemostatic Treatment of Esophageal and Gastric Variceal Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renmin Hospital of Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Remazolam besylate was used for sedation during endoscopic hemostasis in patients with esophageal and gastric varices rupture and bleeding in liver cirrhosis. The onset time, recovery time and incidence of adverse reactions were observed.
Detailed Description
Esophagogastric variceal bleeding (EGVB) is one of the most serious and common complications of liver cirrhosis. Endoscopic hemostasis is the most widely used and important method for the prevention and treatment of EGVB. The treatment of varicose veins hemostasis under gastroscope has the problem of long operation time. Patients are prone to nausea, vomiting and excessive secretions due to nervousness and fear, which affect endoscopic insertion and observation, leading to failure of ligation and massive bleeding, and even death. Therefore, appropriate analgesic and sedative drugs are necessary to ensure endoscopic treatment and improve the prognosis. Remimazolam, an ultra-short-acting benzodiazepine drug, is obtained by introducing metabolizable methyl propionate side chain into midazolam. It may have a good effect on sedation during endoscopic hemostasis in cirrhotic patients with ruptured esophageal and gastric varices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Hemostasis, Sedation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
The control group was sedated with propofol
Arm Title
Remimazolam besylate
Arm Type
Experimental
Arm Description
The experimental group was given remazolam besylate for sedation
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Active Comparator
Intervention Description
Remifentanil maintenance analgesic dose was 1.2-9 μg/kg/h. If the CPOT score ≥3 at the time of maintenance administration, dose adjustment can be considered. Propofol was used for sedation at a loading dose of 0.5mg/kg and a maintenance dose of 1.5mg/kg/h.
Intervention Type
Drug
Intervention Name(s)
Remimazolam besylate
Other Intervention Name(s)
Experimental
Intervention Description
Remifentanil was administered at a maintenance dose of 1.2-9 μg/kg/h for analgesia. If CPOT score ≥3 during maintenance administration, dose adjustment could be considered. For sedation, remazolam besylate was given a load of 0.1-0.2mg/kg and a maintenance dose of 0.1-0.3mg/kg/h.
Primary Outcome Measure Information:
Title
Sedation scores
Description
sedation scores were performed during administration,Richmond Agitation-Sedation Scale(RASS)1~-2 was defined as compliance,Otherwise, sedation was considered inadequate
Time Frame
From the begin to 48 hours after procedure
Secondary Outcome Measure Information:
Title
Rate of adverse events
Description
Any adverse events that occurred during the administration of the drug, such as bradycardia, hypotension, respiratory depression, etc
Time Frame
Within 2 hours from the start of administration to the end of administration
Title
Vital signs
Description
Systolic and Diastolic Blood Pressure
Time Frame
From the begin to 48 hours after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with bleeding from ruptured esophageal and gastric varices
Endoscopic hemostatic treatment was performed
Body Mass Index(BMI)18~28kg/m2
Exclusion Criteria:
History or evidence of increased risk of sedation/anesthesia;
Pregnant and lactating women;
Have participated in other drug trials within 30 days prior to enrollment;
those with contraindications to propofol, opioids and their remedies;
Unwilling to sign informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Wang
Phone
15927142942
Email
410669243@qq.com
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Wang
Phone
15927142942
Email
410669243@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All data will be shared with team members
Learn more about this trial
Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding
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