Hypotension After Anesthetic Induction With Remimazolam in Elderly

May 31, 2023 updated by: Eunah Cho, MD, Kangbuk Samsung Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
12 mg/kg/hr until loss of consciousness

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Investigators

  • Principal Investigator: Eunah Cho, PhD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMZ_bolcon_old

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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