Effects of Changes in Autonomic Nervous Activity on Changes in Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol

Daegu Catholic University Medical Center1 site in 1 country78 target enrollmentDecember 19, 2022

ConditionsGeneral Anesthetics

InterventionsAnesthesia induction with propofol Anesthesia induction with remimazolam

Overview

Phase: Phase 3
Intervention: Anesthesia induction with propofol
Conditions: General Anesthetics
Sponsor: Daegu Catholic University Medical Center
Enrollment: 78
Locations: 1
Primary Endpoint: Difference in low-to-high frequency power ratio (LF/HF) of heart rate variability (HRV) between 5-minute-pre-anesthesia and 5-minute-post-anesthesia induction
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to compare the effects of changes in autonomic nervous activity on changes in blood pressure after anesthesia induction between propofol and remimazolam in patients undergoing low-risk surgery. The main questions it aims to answer are:

Does remimazolam shift sympathovagal balance toward parasympathetic predominance less than propofol?
Does the less shift in sympathovagal balance toward parasympathetic predominance attenuate the reduction in blood pressure? Participants will be administered either propofol or remimazolam for anesthesia induction, after which the autonomic nervous activity and blood pressure will be measured.

Researchers will compare the propofol and remimazolam groups to see if remimazolam causes less shift in sympathovagal balance toward parasympathetic predominance and subsequently attenuates the reduction in blood pressure.

Registry

clinicaltrials.gov

Start Date

December 19, 2022

End Date

September 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daegu Catholic University Medical Center

Responsible Party

Principal Investigator

JongHae Kim

Professor

Daegu Catholic University Medical Center

Eligibility Criteria

Inclusion Criteria

•Age between 20 and 60 years
•American Society of Anesthesiologists physical status of 1
•Elective low-risk surgery requiring general anesthesia, the duration of which is shorter than 2 hours and 30 minutes (e.g., Laparoscopic cholecystectomy, Functional endoscopic sinus surgery, etc.)
•Body mass index less than 30 kg/m2

Exclusion Criteria

•Arrhythmias or cardiac conduction disorders
•Disease or medical conditions affecting autonomic nervous activity (hypertension, diabetes mellitus, ischemic heart disease, congestive heart failure, cerebrovascular accident, chronic kidney disease, thyroid dysfunction, etc.)
•Valvular heart disease
•Use of medications affecting autonomic nervous activity or cardiac conduction (e.g., beta blocker)
•Limited mouth opening, limited head and upper neck extension, history of obstructive sleep apnea, or Modified Mallampati class 3 or 4
•Serum electrolyte abnormalities
•Severe hypovolemia
•Psychiatric diseases

Arms & Interventions

Propofol group

Receives propofol for anesthesia induction

Intervention: Anesthesia induction with propofol

Remimazolam group

Receives remimazolam for anesthesia induction

Intervention: Anesthesia induction with remimazolam

Outcomes

Primary Outcomes

Difference in low-to-high frequency power ratio (LF/HF) of heart rate variability (HRV) between 5-minute-pre-anesthesia and 5-minute-post-anesthesia induction

Time Frame: Between 5 minutes before and after anesthesia induction

Low-frequency power (LF) and high-frequency power (HF) of heart rate variability (HRV) were calculated with the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. LF/HF represents the sympathovagal balance.

Secondary Outcomes

Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before surgical incision(5 minutes before surgical incision)
Standard deviation of the RR intervals of normal sinus beats originating from the sinoatrial node of the right atrium (SDNN) during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
The percentage of adjacent normal-to-normal sinus beat RR intervals that have a more than 50 milliseconds difference between them (pNN50) during 5 minutes before surgical incision(5 minutes before surgical incision)
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Total power (TP) of heart rate variability (HRV) during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Total power (TP) of heart rate variability (HRV) during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before surgical incision(5 minutes before surgical incision)
Total power (TP) of heart rate variability (HRV) during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
Total power (TP) of heart rate variability (HRV) during 5 minutes before surgical incision(5 minutes before surgical incision)
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes before surgical incision(5 minutes before surgical incision)
Standard deviation of the RR intervals of normal sinus beats originating from the sinoatrial node of the right atrium (SDNN) during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Standard deviation of the RR intervals of normal sinus beats originating from the sinoatrial node of the right atrium (SDNN) during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
The percentage of adjacent normal-to-normal sinus beat RR intervals that have a more than 50 milliseconds difference between them (pNN50) during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes before surgical incision(5 minutes before surgical incision)
The percentage of adjacent normal-to-normal sinus beat RR intervals that have a more than 50 milliseconds difference between them (pNN50) during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
The percentage of adjacent normal-to-normal sinus beat RR intervals that have a more than 50 milliseconds difference between them (pNN50) during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Standard deviation of the RR intervals of normal sinus beats originating from the sinoatrial node of the right atrium (SDNN) during 5 minutes before surgical incision(5 minutes before surgical incision)
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before surgical incision(5 minutes before surgical incision)
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before surgical incision(5 minutes before surgical incision)
Mean arterial blood pressure during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Mean arterial blood pressure during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Mean arterial blood pressure during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
Mean arterial blood pressure during 5 minutes before surgical incision(5 minutes before surgical incision)
Systolic blood pressure during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Systolic blood pressure during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Systolic blood pressure during 5 minutes after endotracheal intubation(5 minutes after endotracheal intubation)
Systolic blood pressure during 5 minutes before surgical incision(5 minutes before surgical incision)
Bispectral index (BIS) during 5 minutes before anesthesia induction(5 minutes before anesthesia induction)
Bispectral index (BIS) during 5 minutes after anesthesia induction(5 minutes after anesthesia induction)
Bispectral index (BIS) during 5 minutes after endotracheal intubation(5 minutes after anesthesia induction)
Bispectral index (BIS) during 5 minutes before surgical incision(5 minutes before surgical incision)