Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding

Sponsor

Renmin Hospital of Wuhan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05554965

Collaborator

(none)

Enrollment

Location

Arms

10.6

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Hemostasis Sedation	Drug: Propofol Drug: Remimazolam besylate	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 10, 2022

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: propofol The control group was sedated with propofol	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. Other Names: Active Comparator
Experimental: Remimazolam besylate The experimental group was given remazolam besylate for sedation	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. Other Names: Experimental

Arm

Intervention/Treatment

Active Comparator: propofol

The control group was sedated with propofol

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.

Other Names:

Active Comparator

Experimental: Remimazolam besylate

The experimental group was given remazolam besylate for sedation

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.

Other Names:

Experimental

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renmin Hospital of Wuhan University	Wuhan	Hubei	China

Sponsors and Collaborators

Renmin Hospital of Wuhan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Renmin Hospital of Wuhan University

ClinicalTrials.gov Identifier:

NCT05554965

Other Study ID Numbers:

20220819

First Posted:

Sep 26, 2022

Last Update Posted:

Nov 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemorrhage

Propofol

Study Results

No Results Posted as of Nov 10, 2022