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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
78
After a 10-minute-long acclimation, general anesthesia is induced with 2% propofol at the effect-site concentration of 4 μg/ml based on the Marsh Pharmacokinetic model. The effect-site concentration was maintained at 4 μg/ml until the trachea was intubated. Five minutes after the anesthesia induction, remifentanil was administered at the effect-site concentration of 4 ng/ml based on the Minto pharmacokinetic model until the trachea was intubated. With the initiation of remifentanil infusion, 1 mg/kg of rocuronium was administered following the calibration of the neuromuscular monitoring device. With the train-of-four count of 0, the trachea was intubated. Then, the effect-site concentrations of propofol and remifentanil were decreased to 3 μg/ml and 0 ng/ml, respectively, until the surgical incision was made.
After a 10-minute-long acclimation, general anesthesia is induced with a 2-minute-long infusion of remimazolam at a rate of 12 mg/kg/hr, after which the infusion rate was reduced to 1 mg/kg/hr and was maintained until the surgical incision was made. Five minutes after the anesthesia induction, remifentanil was administered at the effect-site concentration of 4 ng/ml based on the Minto pharmacokinetic model until the trachea was intubated. With the initiation of remifentanil infusion, 1 mg/kg of rocuronium was administered following the calibration of the neuromuscular monitoring device. With the train-of-four count of 0, the trachea was intubated. Then, the effect-site concentration of remifentanil was decreased to 0 ng/ml until the surgical incision was made.
Daegu Catholic University Medical Center
Daegu, South Korea
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
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.
Time frame: Between 5 minutes before and after anesthesia induction
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before anesthesia induction
Low-frequency power (LF) of heart rate variability (HRV) were calculated by integrating power spectra between 0.04 and 0.15 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. LF represents the combined sympathetic and parasympathetic modulation of heart rate via baroreceptor reflexes, but is mainly modulated by sympathetic nervous activity.
Time frame: 5 minutes before anesthesia induction
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes after anesthesia induction
Low-frequency power (LF) of heart rate variability (HRV) were calculated by integrating power spectra between 0.04 and 0.15 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. LF represents the combined sympathetic and parasympathetic modulation of heart rate via baroreceptor reflexes, but is mainly modulated by sympathetic nervous activity.
Time frame: 5 minutes after anesthesia induction
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
Low-frequency power (LF) of heart rate variability (HRV) were calculated by integrating power spectra between 0.04 and 0.15 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. LF represents the combined sympathetic and parasympathetic modulation of heart rate via baroreceptor reflexes, but is mainly modulated by sympathetic nervous activity.
Time frame: 5 minutes after endotracheal intubation
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before surgical incision
Low-frequency power (LF) of heart rate variability (HRV) were calculated by integrating power spectra between 0.04 and 0.15 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. LF represents the combined sympathetic and parasympathetic modulation of heart rate via baroreceptor reflexes, but is mainly modulated by sympathetic nervous activity.
Time frame: 5 minutes before surgical incision
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before anesthesia induction
High-frequency power (HF) of heart rate variability (HRV) were calculated by integrating power spectra between 0.15 and 0.4 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. HF represents the parasympathetic modulation of heart rate in response to respiration.
Time frame: 5 minutes before anesthesia induction
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes after anesthesia induction
High-frequency power (HF) of heart rate variability (HRV) were calculated by integrating power spectra between 0.15 and 0.4 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. HF represents the parasympathetic modulation of heart rate in response to respiration.
Time frame: 5 minutes after anesthesia induction
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
High-frequency power (HF) of heart rate variability (HRV) were calculated by integrating power spectra between 0.15 and 0.4 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. HF represents the parasympathetic modulation of heart rate in response to respiration.
Time frame: 5 minutes after endotracheal intubation
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before surgical incision
High-frequency power (HF) of heart rate variability (HRV) were calculated by integrating power spectra between 0.15 and 0.4 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. HF represents the parasympathetic modulation of heart rate in response to respiration.
Time frame: 5 minutes before surgical incision
Total power (TP) of heart rate variability (HRV) during 5 minutes before anesthesia induction
Total power (TP) of heart rate variability (HRV) were calculated by integrating power spectra between 0 and 0.4 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. TP represents the overall activity of the autonomic nervous system.
Time frame: 5 minutes before anesthesia induction
Total power (TP) of heart rate variability (HRV) during 5 minutes after anesthesia induction
Total power (TP) of heart rate variability (HRV) were calculated by integrating power spectra between 0 and 0.4 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. TP represents the overall activity of the autonomic nervous system.
Time frame: 5 minutes after anesthesia induction
Total power (TP) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
Total power (TP) of heart rate variability (HRV) were calculated by integrating power spectra between 0 and 0.4 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. TP represents the overall activity of the autonomic nervous system.
Time frame: 5 minutes after endotracheal intubation
Total power (TP) of heart rate variability (HRV) during 5 minutes before surgical incision
Total power (TP) of heart rate variability (HRV) were calculated by integrating power spectra between 0 and 0.4 Hz, which were obtained from the Fast Fourier Transform applied to a 5-minute-long electrocardiogram (ECG) waveform. TP represents the overall activity of the autonomic nervous system.
Time frame: 5 minutes before surgical incision
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes before 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.
Time frame: 5 minutes before anesthesia induction
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes 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.
Time frame: 5 minutes after anesthesia induction
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
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.
Time frame: 5 minutes after endotracheal intubation
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes before surgical incision
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.
Time frame: 5 minutes before surgical incision
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes before anesthesia induction
RMSSD represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 5 minutes before anesthesia induction
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes after anesthesia induction
RMSSD represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 5 minutes after anesthesia induction
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes after endotracheal intubation
RMSSD represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 5 minutes after endotracheal intubation
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes before surgical incision
RMSSD represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 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
SDNN represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 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
SDNN represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 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 after endotracheal intubation
SDNN represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 5 minutes after endotracheal intubation
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
SDNN represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 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 before anesthesia induction
pNN50 represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 5 minutes before 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 anesthesia induction
pNN50 represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 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
pNN50 represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 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
pNN50 represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Time frame: 5 minutes before surgical incision
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before anesthesia induction
A Poincaré plot is a scatter plot where each pair of preceding and succeeding RR intervals is plotted on the abscissa and ordinate, respectively. After fitting the ellipse around the plot, SD1 is calculated as the standard deviation of the distance of each point from the line of identity (y=x). SD1 reflects the short-term HRV as the length of the transverse axis of the ellipse. SD1 correlates with the baroreflex sensitivity and HF.
Time frame: 5 minutes before anesthesia induction
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after anesthesia induction
A Poincaré plot is a scatter plot where each pair of preceding and succeeding RR intervals is plotted on the abscissa and ordinate, respectively. After fitting the ellipse around the plot, SD1 is calculated as the standard deviation of the distance of each point from the line of identity (y=x). SD1 reflects the short-term HRV as the length of the transverse axis of the ellipse. SD1 correlates with the baroreflex sensitivity and HF.
Time frame: 5 minutes after anesthesia induction
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after endotracheal intubation
A Poincaré plot is a scatter plot where each pair of preceding and succeeding RR intervals is plotted on the abscissa and ordinate, respectively. After fitting the ellipse around the plot, SD1 is calculated as the standard deviation of the distance of each point from the line of identity (y=x). SD1 reflects the short-term HRV as the length of the transverse axis of the ellipse. SD1 correlates with the baroreflex sensitivity and HF.
Time frame: 5 minutes after endotracheal intubation
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before surgical incision
A Poincaré plot is a scatter plot where each pair of preceding and succeeding RR intervals is plotted on the abscissa and ordinate, respectively. After fitting the ellipse around the plot, SD1 is calculated as the standard deviation of the distance of each point from the line of identity (y=x). SD1 reflects the short-term HRV as the length of the transverse axis of the ellipse. SD1 correlates with the baroreflex sensitivity and HF.
Time frame: 5 minutes before surgical incision
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before anesthesia induction
A Poincaré plot is a scatter plot where each pair of preceding and succeeding RR intervals is plotted on the abscissa and ordinate, respectively. After fitting the ellipse around the plot, SD2 is calculated as the standard deviation of the distance of each point from the line passing through the centroid, which vertically intersects the line of identity (y=x). SD2 reflects the long-term HRV as the length of the long axis of the ellipse. SD2 correlates with the baroreflex sensitivity and LF.
Time frame: 5 minutes before anesthesia induction
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after anesthesia induction
A Poincaré plot is a scatter plot where each pair of preceding and succeeding RR intervals is plotted on the abscissa and ordinate, respectively. After fitting the ellipse around the plot, SD2 is calculated as the standard deviation of the distance of each point from the line passing through the centroid, which vertically intersects the line of identity (y=x). SD2 reflects the long-term HRV as the length of the long axis of the ellipse. SD2 correlates with the baroreflex sensitivity and LF.
Time frame: 5 minutes after anesthesia induction
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after endotracheal intubation
A Poincaré plot is a scatter plot where each pair of preceding and succeeding RR intervals is plotted on the abscissa and ordinate, respectively. After fitting the ellipse around the plot, SD2 is calculated as the standard deviation of the distance of each point from the line passing through the centroid, which vertically intersects the line of identity (y=x). SD2 reflects the long-term HRV as the length of the long axis of the ellipse. SD2 correlates with the baroreflex sensitivity and LF.
Time frame: 5 minutes after endotracheal intubation
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before surgical incision
A Poincaré plot is a scatter plot where each pair of preceding and succeeding RR intervals is plotted on the abscissa and ordinate, respectively. After fitting the ellipse around the plot, SD2 is calculated as the standard deviation of the distance of each point from the line passing through the centroid, which vertically intersects the line of identity (y=x). SD2 reflects the long-term HRV as the length of the long axis of the ellipse. SD2 correlates with the baroreflex sensitivity and LF.
Time frame: 5 minutes before surgical incision
Mean arterial blood pressure during 5 minutes before anesthesia induction
Measured at any time during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
Mean arterial blood pressure during 5 minutes after anesthesia induction
Mean arterial blood pressure corresponding to the lowest systolic blood pressure during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
Mean arterial blood pressure during 5 minutes after endotracheal intubation
Measured at any time during 5 minutes after endotracheal intubation
Time frame: 5 minutes after endotracheal intubation
Mean arterial blood pressure during 5 minutes before surgical incision
Measured at any time during 5 minutes before surgical incision
Time frame: 5 minutes before surgical incision
Systolic blood pressure during 5 minutes before anesthesia induction
Measured at any time during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
Systolic blood pressure during 5 minutes after anesthesia induction
The lowest systolic blood pressure during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
Systolic blood pressure during 5 minutes after endotracheal intubation
Measured at any time during 5 minutes after endotracheal intubation
Time frame: 5 minutes after endotracheal intubation
Systolic blood pressure during 5 minutes before surgical incision
Measured at any time during 5 minutes before surgical incision
Time frame: 5 minutes before surgical incision
Bispectral index (BIS) during 5 minutes before anesthesia induction
The BIS value corresponding to blood pressure measured during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
Bispectral index (BIS) during 5 minutes after anesthesia induction
The BIS value corresponding to the lowest systolic blood pressure during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
Bispectral index (BIS) during 5 minutes after endotracheal intubation
The BIS value corresponding to blood pressure measured during 5 minutes after endotracheal intubation
Time frame: 5 minutes after anesthesia induction
Bispectral index (BIS) during 5 minutes before surgical incision
The BIS value corresponding to blood pressure measured during 5 minutes before surgical incision
Time frame: 5 minutes before surgical incision
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