Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding

Sedation Clinical Trial

Official title:

Clinical Study of Remazolam Besylate for Sedation During Endoscopic Hemostatic Treatment of Esophageal and Gastric Variceal Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554965
• Other study ID #: 20220819
• Status: Recruiting
• Phase: Phase 4
• Start date: February 10, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2022
• Source: Renmin Hospital of Wuhan University
• Contact: Lu Wang
• Phone: 15927142942
• Email: 410669243[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopic Hemostasis
• Hemorrhage
• Sedation

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation scores	sedation scores were performed during administration,Richmond Agitation-Sedation Scale(RASS)1~-2 was defined as compliance,Otherwise, sedation was considered inadequate	From the begin to 48 hours after procedure
Secondary	Rate of adverse events	Any adverse events that occurred during the administration of the drug, such as bradycardia, hypotension, respiratory depression, etc	Within 2 hours from the start of administration to the end of administration
Secondary	Vital signs	Systolic and Diastolic Blood Pressure	From the begin to 48 hours after procedure