MedTrace Logo

The Application of Remazolam in Gastroenteroscopy

NCT05357430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-02-19

No results posted yet for this study

Summary

OBJECTIVE: To study the safety, efficacy and clinical significance of remimazolam in the diagnosis and treatment of patients with daytime gastrointestinal endoscopy, calculate the optimal dose, and conduct relevant verification. Provide a safer and more effective anesthesia solution for the growing special population.

METHODS：Around 160 patients were selected to receive painless gastroenteroscopy.，they were divided into four groups of D1, D2, R and C. Group D1 and D2(including 60 patients) were used to calculate the ED50 and ED95 of the drug. According to up-and-down method, they were slowly injected 0.3μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤３. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg. And the study was terminated when seven crossing points occurred. One hundred patients were randomly divided into two groups of R and C.Before administration of remimazolam, remifentanil injection 0.3 μg/kg were given intravenously in two groups, respectively (injection rate was 30 s).Then group R was given the calculated dose of remimazolam, and group C was given propofol 1.5-2mg/kg.The success rate of sedation, changes in vital signs, adverse reactions, and postoperative recovery were recorded in the two groups.

Conditions

  • Gastroenterology

Interventions

DRUG

Remimazolam

0.3μg/kg of remifentanil was injected slowly in advance, then different doses of Remimazolam was injected to two groups of D1 and D2, according to up-and-down method.

DRUG

Remimazolam

0.3μg/kg of remifentanil was injected slowly in advance, then the calculated dose from groups of D1 and D2 of remimazolam was injected to group R.

DRUG

Propofol

0.3μg/kg of remifentanil was injected slowly in advance, then 1.5-2mg/kg of Propofol was injected to group C

Sponsors & Collaborators

  • Yangzhou University

    lead OTHER

Principal Investigators

  • Liu M Yu, Director · Yangzhou University

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-04-01
Completion
2023-08-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357430 on ClinicalTrials.gov