The Application of Remazolam in Gastroenteroscopy

NCT ID: NCT05357430

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-08-01

Brief 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.

Detailed Description

The study used up-and-down methods to calculate the ED50 and ED95. According to up-and-down method, group D1 and D2 were slowly injected 0.5μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤３. The standard for a positive response in patients undergoing gastroscopy: coughing, swallowing, frowning, and physical movement affecting the operation during the examination. 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. Probit regression analysis method was used to calculate the ED50, ED95 and 95%CI of remimazolam combined with remifentanil in painless gastroenteroscopy.

Conditions

Gastroenterology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

group D1(males)

Administration of 0.3μg/kg of remifentanil in advance, then corresponding dose of remimazolam, according to the experimental results of the previous patient.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

group D2(females)

Administration of 0.3μg/kg of remifentanil in advance, then corresponding dose of remimazolam, according to the experimental results of the previous patient.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

group R

Administration of 0.3μg/kg of remifentanil in advance, then the calculated dose of remimazolam, according to the experimental results of the previous patient.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

group C

Administration of 0.3μg/kg of remifentanil in advance, then 1.5-2mg/kg propofol.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Propofol

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years old; ASA classification I-II grade

Exclusion Criteria

• Asthma; allergic to the drugs involved and contraindicated; patients with severe respiratory system, cardiovascular system diseases and coagulation insufficiency of liver and kidney function; patients with severe neuropsychiatric system diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Wang wanxia

Junior Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liu M Yu, Director

Role: PRINCIPAL_INVESTIGATOR

Yangzhou University

Locations

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

2020-YKL12-23

Identifier Type: -

Identifier Source: org_study_id