A Phase 3 interventional study of Anesthesia induction with propofol and Anesthesia induction with remimazolam in General Anesthetics, sponsored by Daegu Catholic University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Daegu Catholic University Medical Center · Phase 3, Interventional, and Prevention
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:
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.
Daegu Catholic University Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives propofol for anesthesia induction
Drug: Anesthesia induction with propofol
Receives remimazolam for anesthesia induction
Drug: Anesthesia induction with remimazolam
Drug page: Propofol
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.
Drug page: Remimazolam
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.
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
Deceleration capacity (DC) during 5 minutes before anesthesia induction
The quasi-periodic decelerations in short-term heart rate are calculated using a phase-rectified signal averaging technique. The calculated deceleration (deceleration capacity: DC) represents parasympathetic nervous activity.
Time frame: 5 minutes before anesthesia induction
Deceleration capacity (DC) during 5 minutes after anesthesia induction
The quasi-periodic decelerations in short-term heart rate are calculated using a phase-rectified signal averaging technique. The calculated deceleration (deceleration capacity: DC) represents parasympathetic nervous activity.
Time frame: 5 minutes after anesthesia induction
Deceleration capacity (DC) during 5 minutes after endotracheal intubation
The quasi-periodic decelerations in short-term heart rate are calculated using a phase-rectified signal averaging technique. The calculated deceleration (deceleration capacity: DC) represents parasympathetic nervous activity.
Time frame: 5 minutes after endotracheal intubation
Deceleration capacity (DC) during 5 minutes before surgical incision
The quasi-periodic decelerations in short-term heart rate are calculated using a phase-rectified signal averaging technique. The calculated deceleration (deceleration capacity: DC) represents parasympathetic nervous activity.
Time frame: 5 minutes before surgical incision
Diastolic 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
Diastolic blood pressure during 5 minutes after anesthesia induction
Diastolic blood pressure corresponding to the lowest systolic blood pressure during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
Diastolic 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
Diastolic 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
Ran from Dec 2022 to primary completion in Sep 2023, 9 months.
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Studies of the drug tested here: Remimazolam
Daegu Catholic University Medical Center