Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol
- Conditions
- General Anesthetics
- Interventions
- Drug: Anesthesia induction with propofolDrug: Anesthesia induction with remimazolam
- Registration Number
- NCT05635201
- Lead Sponsor
- Daegu Catholic University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol group Anesthesia induction with propofol Receives propofol for anesthesia induction Remimazolam group Anesthesia induction with remimazolam Receives remimazolam for anesthesia induction
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method 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) 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.
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) 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.
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) 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.
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before surgical incision 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.
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 SDNN represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
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 pNN50 represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before anesthesia induction 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.
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after anesthesia induction 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.
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after endotracheal intubation 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.
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before anesthesia induction 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.
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) 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.
Total power (TP) of heart rate variability (HRV) during 5 minutes after anesthesia induction 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.
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-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.
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation 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.
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) 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.
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) 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.
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before surgical incision 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.
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) 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.
Total power (TP) of heart rate variability (HRV) during 5 minutes before surgical incision 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.
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes before anesthesia induction 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.
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes before anesthesia induction 5 minutes before anesthesia induction RMSSD represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes after endotracheal intubation 5 minutes after endotracheal intubation RMSSD represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes before surgical incision 5 minutes before surgical incision RMSSD represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
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 SDNN represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
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 SDNN represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Low-to-high-frequency power ratio (LF/HF) of heart rate variability (HRV) during 5 minutes before surgical incision 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.
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 pNN50 represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
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 pNN50 represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
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 pNN50 represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Root mean square of the successive differences of the RR intervals (RMSSD) during 5 minutes after anesthesia induction 5 minutes after anesthesia induction RMSSD represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
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 SDNN represents the parasympathetic nervous activity mediated by a respiratory sinus arrhythmia.
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before surgical incision 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.
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before anesthesia induction 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.
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after anesthesia induction 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.
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after endotracheal intubation 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.
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before surgical incision 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.
Mean arterial blood pressure during 5 minutes before anesthesia induction 5 minutes before anesthesia induction Measured at any time during 5 minutes before anesthesia induction
Mean arterial blood pressure during 5 minutes after anesthesia induction 5 minutes after anesthesia induction Mean arterial blood pressure corresponding to the lowest systolic blood pressure during 5 minutes after anesthesia induction
Mean arterial blood pressure during 5 minutes after endotracheal intubation 5 minutes after endotracheal intubation Measured at any time during 5 minutes after endotracheal intubation
Mean arterial blood pressure during 5 minutes before surgical incision 5 minutes before surgical incision Measured at any time during 5 minutes before surgical incision
Systolic blood pressure during 5 minutes before anesthesia induction 5 minutes before anesthesia induction Measured at any time during 5 minutes before anesthesia induction
Systolic blood pressure during 5 minutes after anesthesia induction 5 minutes after anesthesia induction The lowest systolic blood pressure during 5 minutes after anesthesia induction
Systolic blood pressure during 5 minutes after endotracheal intubation 5 minutes after endotracheal intubation Measured at any time during 5 minutes after endotracheal intubation
Systolic blood pressure during 5 minutes before surgical incision 5 minutes before surgical incision Measured at any time during 5 minutes before surgical incision
Bispectral index (BIS) during 5 minutes before anesthesia induction 5 minutes before anesthesia induction The BIS value corresponding to blood pressure measured during 5 minutes before anesthesia induction
Bispectral index (BIS) during 5 minutes after anesthesia induction 5 minutes after anesthesia induction The BIS value corresponding to the lowest systolic blood pressure during 5 minutes after anesthesia induction
Bispectral index (BIS) during 5 minutes after endotracheal intubation 5 minutes after anesthesia induction The BIS value corresponding to blood pressure measured during 5 minutes after endotracheal intubation
Bispectral index (BIS) during 5 minutes before surgical incision 5 minutes before surgical incision The BIS value corresponding to blood pressure measured during 5 minutes before surgical incision
Trial Locations
- Locations (1)
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of