Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding

Phase 4

• Conditions: Endoscopic Hemostasis; Sedation
• Interventions: Drug: Remimazolam besylate; Drug: Propofol

• Registration Number: NCT05554965
• Lead Sponsor: Renmin Hospital of Wuhan University

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.

Study Timeline

• Study Start: 2022-02-10
• Status Verified: 2022-08
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Primary Completion: 2022-10-30
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-10
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam besylate	Remimazolam besylate	The experimental group was given remazolam besylate for sedation
propofol	Propofol	The control group was sedated with propofol

Primary Outcome Measures

Name	Time	Method
Sedation scores	From the begin to 48 hours after procedure	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

Name	Time	Method
Rate of adverse events	Within 2 hours from the start of administration to the end of administration	Any adverse events that occurred during the administration of the drug, such as bradycardia, hypotension, respiratory depression, etc
Vital signs	From the begin to 48 hours after procedure	Systolic and Diastolic Blood Pressure

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China