Hypotension After Anesthetic Induction with Remimazolam in Elderly

NCT ID: NCT05538741

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-14

Study Completion Date

2024-06-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bolus

Remimazolam bolus injection for 20 seconds

Group Type EXPERIMENTAL

Bolus of remimazolam

Intervention Type DRUG

0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for \>80 years old

Continuous

Remimazolam continuous infusion

Group Type ACTIVE_COMPARATOR

Continuous infusion of remimazolam

Intervention Type DRUG

12 mg/kg/hr until loss of consciousness

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bolus of remimazolam

0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for \>80 years old

Intervention Type DRUG

Continuous infusion of remimazolam

12 mg/kg/hr until loss of consciousness

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eunah Cho, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eunah Cho, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kangbuk Samsung Hospital

Seoul, Seoul, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RMZ_bolcon_old

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.