NCT05538741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

July 14, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 8, 2022

Last Update Submit

September 9, 2024

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

  • The incidence of hypotension

    Systolic blood pressure \< 90 mmHg

    10 minutes after intubation

Secondary Outcomes (5)

  • The incidence of bradycardia

    10 minutes after intubation

  • Number of participants with use of any vasopressors

    10 minutes after intubation

  • Lowest systolic blood pressure

    10 minutes after intubation

  • Time to loss of consciousness

    10 minutes after intubation

  • Total remimazolam used for anesthetic induction

    10 minutes after intubation

Study Arms (2)

Bolus

EXPERIMENTAL

Remimazolam bolus injection for 20 seconds

Drug: Bolus of remimazolam

Continuous

ACTIVE COMPARATOR

Remimazolam continuous infusion

Drug: Continuous infusion of remimazolam

Interventions

Bolus of remimazolamDRUG

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

Bolus
Continuous infusion of remimazolamDRUG

12 mg/kg/hr until loss of consciousness

Continuous

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Eunah Cho, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 14, 2022

Study Start

July 14, 2023

Primary Completion

June 14, 2024

Study Completion

June 14, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

KR(1)