Effects of Remimazolam on the Intraoperative Hemodynamics... | NCT05557253

Studies
Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

NCT05557253

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Oct 27, 2022Actual

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Intraoperative Hypotension

Interventions

Remimazolam
Balanced Anesthesia

Countries

South Korea

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2022Actual

Primary Completion Date

Oct 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Sep 25, 2022

First Submission Date that Met QC Criteria

Sep 25, 2022

First Posted Date

Sep 27, 2022Actual

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

Oct 25, 2022

Last Update Posted Date

Oct 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chang-Hoon Koo, Assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
remimazolam group	Experimental	General anesthesia is induced and maintained with remimazolam.	Drug: Remimazolam
balanced group	Active Comparator	General anesthesia is induced with propofol and maintained with desflurane.	Drug: Balanced Anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remimazolam	Drug	Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h	remimazolam group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraoperative hypotension	Target Systolic Blood Pressure < 80%	During surgery

Secondary Outcomes

Measure	Description	Time Frame
Inotropic requirements	Dose of inotropics administered during surgery	During surgery
Incidence of bradycardia	heart rate < 40 /min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who undergo elective extracranial-intracranial bypass surgery
American Society of Anesthesiologists grade 1,2,3
Age > 18 years old

Exclusion Criteria:

Refuse to participate to the study
American Society of Anesthesiologists grade 4
Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
Allergic history of benzodiazepine
Pregnant
Acute narrow-angle glaucoma
Shock or Coma
Acute alcohol addicted
Obstructive sleep apnea
dependency on alcohol or drug
Severe acute respiratory insufficiency
Hypersensitivity to Dextran 40

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chang-Hoon Koo	Contact	+821085098841		vollock9@gmail.com

Overall Officials

Name	Affiliation	Role
Chang-Hoon Koo	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	13620	South Korea

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

Intervention Browse Module

MeSH Terms

ID	Term
C522201	remimazolam
D058126	Balanced Anesthesia

Ancestor Terms

ID	Term
D000768	Anesthesia, General
D000758	Anesthesia
D000760	Anesthesia and Analgesia

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Browse Branches

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