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OpenTrials
Completed

NCT Number: NCT05538741

Hypotension After Anesthetic Induction with Remimazolam in Elderly

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Continuous infusion of remimazolam

Drug

12 mg/kg/hr until loss of consciousness

Primary outcomes

  1. The incidence of hypotension

    Time frame: 10 minutes after intubation

    Systolic blood pressure < 90 mmHg

Secondary outcomes

  1. The incidence of bradycardia

    Time frame: 10 minutes after intubation

    Heart rate < 40 beats per minute

  2. Number of participants with use of any vasopressors

    Time frame: 10 minutes after intubation

    Use of ephedrine, phenylephrine

  3. Lowest systolic blood pressure

    Time frame: 10 minutes after intubation

    The lowest systolic blood pressure measured within10 minutes after intubation

  4. 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.

  5. Total remimazolam used for anesthetic induction

    Time frame: 10 minutes after intubation

    Sum of remimazolam used during anesthetic induction

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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