Efficacy and Safety of Remimazolam Besylate Versus Propof... | NCT04790734

Studies
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

NCT04790734

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Sep 15, 2022Actual

Enrollment

60Actual

Phase

Phase 2

Conditions

Critical Illness

Interventions

Sedation drugs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2021Actual

Primary Completion Date

Apr 12, 2022Actual

Completion Date

May 12, 2022Actual

First Submitted Date

Mar 8, 2021

First Submission Date that Met QC Criteria

Mar 9, 2021

First Posted Date

Mar 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2022

Last Update Posted Date

Sep 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaobo Yang, MD, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.

Detailed Description

This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remimazolam	Experimental	Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.	Drug: Sedation drugs
Propofol	Active Comparator	Patients in the propofol group received propofol at an initial infusion rate of 2.0 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.	Drug: Sedation drugs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sedation drugs	Drug	Different sedation drugs	Propofol Remimazolam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of time in the target sedation range without rescue sedation	The percentage of time in the target sedation range without rescue sedation	From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first

Secondary Outcomes

Measure	Description	Time Frame
Length of ICU stay	Length of ICU stay	From start of study to 28 days
28-day mortality	28-day mortality	From start of study to 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 and ≤ 75 years;
Intubated and mechanically ventilated ≤96 hours before enrollment；
Expected to require continuous invasive ventilation and sedation ≥24 hours;
Requirement for light to moderate sedation (a RASS score of -3 to 0).

Exclusion Criteria:

Body mass index (BMI) <18 or >30 kg/m2;
Acute severe neurological disorder and any other condition interfering with RASS assessment;
Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
Heart rate less than 50 beats/min;
Second- or third-degree heart block in the absence of a pacemaker;
Unstable angina;
Acute myocardial infarction;
Left ventricular ejection fraction less than 30%;
Contraindicate or allergic to study drugs;
Moribund state;
Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
Chronic kidney disease with glomerular filtration rate (GFR) < 60 ml/min/1.73m2;
Alcohol abuse;
Myasthenia gravis;
Pregnancy or lactation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
You Shang, Professor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology		Wuhan			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Feb 7, 2023
Reset	Nov 16, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 7, 2023			Nov 16, 2023

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided