The Application of Remazolam in Gastroenteroscopy

Yangzhou University

Status

Completed

Conditions

Gastroenterology

Treatments

Drug: Remimazolam

Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT05357430

2020-YKL12-23

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

83 participants in 4 patient groups

group D1(males)

Experimental group

Description:

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

Treatment:

Drug: Remimazolam

group D2(females)

Experimental group

Description:

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

Treatment:

Drug: Remimazolam

group R

Experimental group

Description:

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

Treatment:

Drug: Remimazolam

group C

Experimental group

Description:

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

Treatment:

Drug: Propofol