Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding

NCT ID: NCT05554965

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2022-12-30

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.

Conditions

Endoscopic Hemostasis; Sedation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

propofol

The control group was sedated with propofol

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Remimazolam besylate

The experimental group was given remazolam besylate for sedation

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

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.

Interventions

Propofol

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

Remimazolam besylate

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.

Intervention Type: DRUG

Other Intervention Names

Active Comparator; Experimental

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Wang

Role: CONTACT

410669243@qq.com

15927142942

Facility Contacts

Lu Wang

Role: primary

410669243@qq.com

15927142942

Other Identifiers

20220819

Identifier Type: -

Identifier Source: org_study_id