Hypotension After Anesthetic Induction With Remimazolam in Elderly

Sponsor

Kangbuk Samsung Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05538741

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypotension	Drug: Bolus of remimazolam Drug: Continuous infusion of remimazolam	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Comparison of the Incidence of Hypotension With Bolus Versus Continuous Remimazolam for Anesthetic Induction in Elderly Patients

Anticipated Study Start Date :

Dec 31, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bolus Remimazolam bolus injection for 20 seconds	Drug: Bolus of remimazolam 0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for >80 years old
Active Comparator: Continuous Remimazolam continuous infusion	Drug: Continuous infusion of remimazolam 6 mg/kg/hr until loss of consciousness

Arm

Intervention/Treatment

Experimental: Bolus

Remimazolam bolus injection for 20 seconds

Drug: Bolus of remimazolam

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

Active Comparator: Continuous

Remimazolam continuous infusion

Drug: Continuous infusion of remimazolam

6 mg/kg/hr until loss of consciousness

Outcome Measures

Primary Outcome Measures

The incidence of hypotension [10 minutes after intubation]
Systolic blood pressure < 90 mmHg

Secondary Outcome Measures

The incidence of bradycardia [10 minutes after intubation]
Heart rate < 40 beats per minute
Number of participants with use of any vasopressors [10 minutes after intubation]
Use of ephedrine, phenylephrine
Lowest systolic blood pressure [10 minutes after intubation]
The lowest systolic blood pressure measured within10 minutes after intubation
Time to loss of consciousness [10 minutes after intubation]
Time to loss of consciousness. Loss of consciousness is assessed by the loss of response to shoulder shaking.
Total remimazolam used for anesthetic induction [10 minutes after intubation]
Sum of remimazolam used during anesthetic induction

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kangbuk Samsung Hospital

Investigators

Principal Investigator: Eunah Cho, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eunah Cho, MD, Assistant Professor, Kangbuk Samsung Hospital

ClinicalTrials.gov Identifier:

NCT05538741

Other Study ID Numbers:

RMZ_bolcon_old

First Posted:

Sep 14, 2022

Last Update Posted:

Sep 14, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Sep 14, 2022