Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding

Wuhan University

Status and phase: Enrolling; Phase 4

Conditions: Sedation; Endoscopic Hemostasis

Treatments: Drug: Remimazolam besylate; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05554965

20220819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

propofol

Active Comparator group

Description:

The control group was sedated with propofol

Treatment:

Drug: Propofol

Remimazolam besylate

Experimental group

Description:

The experimental group was given remazolam besylate for sedation

Treatment:

Drug: Remimazolam besylate