Back to resultsPharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU
Primary Purpose
Intensive Care Unit, Mechanical Ventilation, Anesthesia
Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Remimazolam 0.1mg/kg/h
Remimazolam 0.3mg/kg/h
Remimazolam 0.5mg/kg/h
Sponsored by
About this trial
This is an interventional treatment trial for Intensive Care Unit focused on measuring Remimazolam, Intensive Care Unit, Mechanical Ventilation, Anesthesia, Sedation, Liver Failure, Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
Patients admitted to ICU for tracheal intubation and mechanical; Patients aged >18 years; Patients with expected mechanical ventialation time >24 hours.
Exclusion Criteria:
Patients on long-term anti-anxiety medication or sleeping pills; Patients with known or suspected hypersensitivity to remimazolam; Patients with severe central nervous system diseases; Patients who do not wish to sign the informed consent form.
Sites / Locations
- The First Affiliated Hospital with Nanjing Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Remimazolam 0.1mg/kg/h
Remimazolam 0.3mg/kg/h
Remimazolam 0.5mg/kg/h
Arm Description
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h.
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h.
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h.
Outcomes
Primary Outcome Measures
Plasma concentration of Remimazolam
Plasma concentration of Remimazolam
Secondary Outcome Measures
Adverse reactions
Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate
Full Information
NCT ID
NCT05480787
First Posted
July 27, 2022
Last Updated
July 27, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05480787
Brief Title
Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU
Official Title
Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU : Establishment of Population Pharmacokinetic Model and Exploration of Clinical Influencing Factors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit, Mechanical Ventilation, Anesthesia, Liver Failure, Pharmacokinetics
Keywords
Remimazolam, Intensive Care Unit, Mechanical Ventilation, Anesthesia, Sedation, Liver Failure, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam 0.1mg/kg/h
Arm Type
Experimental
Arm Description
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h.
Arm Title
Remimazolam 0.3mg/kg/h
Arm Type
Experimental
Arm Description
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h.
Arm Title
Remimazolam 0.5mg/kg/h
Arm Type
Experimental
Arm Description
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h.
Intervention Type
Drug
Intervention Name(s)
Remimazolam 0.1mg/kg/h
Intervention Description
Remimazolam Tosilate for Injection(36mg)
Intervention Type
Drug
Intervention Name(s)
Remimazolam 0.3mg/kg/h
Intervention Description
Remimazolam Tosilate for Injection(36mg)
Intervention Type
Drug
Intervention Name(s)
Remimazolam 0.5mg/kg/h
Intervention Description
Remimazolam Tosilate for Injection(36mg)
Primary Outcome Measure Information:
Title
Plasma concentration of Remimazolam
Description
Plasma concentration of Remimazolam
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Adverse reactions
Description
Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted to ICU for tracheal intubation and mechanical; Patients aged >18 years; Patients with expected mechanical ventialation time >24 hours.
Exclusion Criteria:
Patients on long-term anti-anxiety medication or sleeping pills; Patients with known or suspected hypersensitivity to remimazolam; Patients with severe central nervous system diseases; Patients who do not wish to sign the informed consent form.
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
225500
Country
China
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU
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