Clinical trial NCT05635201: Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol
Official title: Effects of Changes in Autonomic Nervous Activity on Changes in Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: General Anesthetics
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
Collaborators: name: Hana Pharm Co., Ltd.
First posted: 2022-12-02
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: Between 5 minutes before and after anesthesia induction
Secondary outcomes:
measure: Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: High-frequency power (HF) of heart rate variability (HRV) during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: High-frequency power (HF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: Total power (TP) of heart rate variability (HRV) during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Total power (TP) of heart rate variability (HRV) during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Total power (TP) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Total power (TP) of heart rate variability (HRV) during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: 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
timeFrame: 5 minutes before anesthesia induction
measure: 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
timeFrame: 5 minutes after anesthesia induction
measure: 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
timeFrame: 5 minutes after endotracheal intubation
measure: 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
timeFrame: 5 minutes before surgical incision
measure: 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
timeFrame: 5 minutes before anesthesia induction
measure: 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
timeFrame: 5 minutes after anesthesia induction
measure: 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
timeFrame: 5 minutes after endotracheal intubation
measure: 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
timeFrame: 5 minutes before surgical incision
measure: Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: Mean arterial blood pressure during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Mean arterial blood pressure during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Mean arterial blood pressure during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Mean arterial blood pressure during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: Systolic blood pressure during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Systolic blood pressure during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Systolic blood pressure during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Systolic blood pressure during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: Bispectral index (BIS) during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Bispectral index (BIS) during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Bispectral index (BIS) during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after anesthesia induction
measure: Bispectral index (BIS) during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
Other outcomes:
measure: Deceleration capacity (DC) during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Deceleration capacity (DC) during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Deceleration capacity (DC) during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Deceleration capacity (DC) during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
measure: Diastolic blood pressure during 5 minutes before anesthesia induction
timeFrame: 5 minutes before anesthesia induction
measure: Diastolic blood pressure during 5 minutes after anesthesia induction
timeFrame: 5 minutes after anesthesia induction
measure: Diastolic blood pressure during 5 minutes after endotracheal intubation
timeFrame: 5 minutes after endotracheal intubation
measure: Diastolic blood pressure during 5 minutes before surgical incision
timeFrame: 5 minutes before surgical incision
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jonghae Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: