Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding

NCT05554965 | Unknown Phase 4

• 1 other identifier: 20220819
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Hemostasis; Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of adverse events

  Within 2 hours from the start of administration to the end of administration

• Vital signs

  From the begin to 48 hours after procedure

Study Arms (2)

propofol

ACTIVE COMPARATOR

The control group was sedated with propofol

Drug: Propofol

Remimazolam besylate

EXPERIMENTAL

The experimental group was given remazolam besylate for sedation

Drug: Remimazolam besylate

Interventions

Propofol 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.

Also known as: Active Comparator

propofol

Remimazolam besylate 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.

Also known as: Experimental

Remimazolam besylate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with bleeding from ruptured esophageal and gastric varices
• Endoscopic hemostatic treatment was performed
• Body Mass Index(BMI)18～28kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Lu Wang

CONTACT

15927142942; 410669243@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 26, 2022
• Study Start: February 10, 2022
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)