The Application of Remazolam in Gastroenteroscopy

NCT05357430 | Completed

• 1 other identifier: 2020-YKL12-23
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenterology

Keywords

Remimazolam

Outcome Measures

Primary Outcomes (3)

• Success rate of sedation

  After the administration of remimazolam, observe and record the response

  1-3minutes

• Blood pressure value

  record the blood pressure before and after administration

  1-30minutes

• Heart rate

  record the heart rate before and after administration

  1-30minutes

Secondary Outcomes (1)

• Incidence of adverse reactions

  1-30minutes

Study Arms (4)

group D1(males)

EXPERIMENTAL

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

Drug: Remimazolam

group D2(females)

EXPERIMENTAL

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

Drug: Remimazolam

group R

EXPERIMENTAL

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

Drug: Remimazolam

group C

EXPERIMENTAL

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

Drug: Propofol

Interventions

Remimazolam 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 D1(males); group D2(females)

Propofol DRUG

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

group C

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225000, China

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Liu M Yu, Director

  Yangzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Investigator

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 2, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CN (1)