Hypotension After Anesthetic Induction with Remimazolam i... | NCT05538741

Studies
Hypotension After Anesthetic Induction with Remimazolam in Elderly

NCT05538741

Sponsor

Kangbuk Samsung Hospital

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Hypotension

Interventions

Bolus of remimazolam
Continuous infusion of remimazolam

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

Sep 2024

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

Jul 14, 2023Actual

Primary Completion Date

Jun 14, 2024Actual

Completion Date

Jun 14, 2024Actual

First Submitted Date

Sep 8, 2022

First Submission Date that Met QC Criteria

Sep 12, 2022

First Posted Date

Sep 14, 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

Sep 9, 2024

Last Update Posted Date

Sep 19, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Remimazolam can be administered either bolus or continuous for anesthetic induction. In our study the investigators aimed to compare the incidence of hypotension after anesthetic induction using remimazolam by bolus injection and continuous infusion in elderly patients.

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

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bolus	Experimental	Remimazolam bolus injection for 20 seconds	Drug: Bolus of remimazolam
Continuous	Active Comparator	Remimazolam continuous infusion	Drug: Continuous infusion of remimazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bolus of remimazolam	Drug	0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for >80 years old	Bolus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of hypotension	Systolic blood pressure < 90 mmHg	10 minutes after intubation

Secondary Outcomes

Measure	Description	Time Frame
The incidence of bradycardia	Heart rate < 40 beats per minute	10 minutes after intubation
Number of participants with use of any vasopressors	Use of ephedrine, phenylephrine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elderly patients with age over 60 years old
scheduled for elective surgery under general anesthesia
American Society of Anesthesiology Physical Status I-III

Exclusion Criteria:

Arrhythmia
Liver dysfunction
Kidney dysfunction
Uncontrolled hypertension
Uncontrolled diabetes mellitus
Allergic to benzodiazepines
Heart failure
Drug intoxication
Alcoholics
Cognitive dysfunction
Unable to understand and consent voluntarily

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eunah Cho, PhD	Assistant Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangbuk Samsung Hospital		Seoul	Seoul		South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided