Hypotension After Anesthetic Induction With Remimazolam in Elderly

Not Applicable

Not yet recruiting

• Conditions: Hypotension
• Interventions: Drug: Bolus of remimazolam; Drug: Continuous infusion of remimazolam

• Registration Number: NCT05538741
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02
• Study Start: 2023-06-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus	Bolus of remimazolam	Remimazolam bolus injection for 20 seconds
Continuous	Continuous infusion of remimazolam	Remimazolam continuous infusion

Primary Outcome Measures

Name	Time	Method
The incidence of hypotension	10 minutes after intubation	Systolic blood pressure \< 90 mmHg

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of