General AnestheticsPhase 3NCT05635201
Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol
A Phase 3 study testing Anesthesia induction with propofol and Anesthesia induction with remimazolam in people with General Anesthetics, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- General Anesthetics
- What is being tested?
- Anesthesia induction with propofol and Anesthesia induction with remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2022to 30 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Changes in Autonomic Nervous Activity on Changes in Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol
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.
- Conditions
- General Anesthetics
- Being tested
- Anesthesia induction with propofol, Anesthesia induction with remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia induction with propofolDrug
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.
Anesthesia induction with remimazolamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | Receives propofol for anesthesia induction Receives: Drug: Anesthesia induction with propofol |
| Remimazolam group | Experimental | Receives remimazolam for anesthesia induction Receives: Drug: Anesthesia induction with remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 5 minutes before and after anesthesia induction
Secondary outcomes (48)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 minutes before surgical incision
Systolic blood pressure during 5 minutes before anesthesia induction
Measured at any time during 5 minutes before anesthesia induction
Measured: 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
Measured: 5 minutes after anesthesia induction
Systolic blood pressure during 5 minutes after endotracheal intubation
Measured at any time during 5 minutes after endotracheal intubation
Measured: 5 minutes after endotracheal intubation
Systolic blood pressure during 5 minutes before surgical incision
Measured at any time during 5 minutes before surgical incision
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 minutes before surgical incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start19 Dec 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnestheticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Responsible party
- Principal investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- Jonghae Kim, M.D., Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635201
- Sponsor's protocol ID
- CR-22-138
- Status last verified
- Oct 2023
- First submitted
- 23 Nov 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Changes in Autonomic Nervous Activity on Changes in Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol
- ClinicalTrials.gov ID
- NCT05635201
- Acronym / sponsor ID
- CR-22-138
- Conditions
- General Anesthetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: Anesthesia induction with propofolReceives propofol for anesthesia induction |
| Remimazolam group | Experimental | Drug: Anesthesia induction with remimazolamReceives remimazolam for anesthesia induction |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia induction with propofolAfter 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 | Propofol group |
| Anesthesia induction with remimazolamAfter 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. | Drug | Remimazolam group |
Primary outcome
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.
48 secondary outcomes
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
Time frame: 5 minutes after endotracheal intubation
Low-frequency power (LF) of heart rate variability (HRV) during 5 minutes before surgical incision
Time frame: 5 minutes before surgical incision
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
Time frame: 5 minutes after endotracheal intubation
High-frequency power (HF) of heart rate variability (HRV) during 5 minutes before surgical incision
Time frame: 5 minutes before surgical incision
Total power (TP) of heart rate variability (HRV) during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
Total power (TP) of heart rate variability (HRV) during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
Total power (TP) of heart rate variability (HRV) during 5 minutes after endotracheal intubation
Time frame: 5 minutes after endotracheal intubation
Total power (TP) of heart rate variability (HRV) during 5 minutes before surgical incision
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: 5 minutes before surgical incision
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes after endotracheal intubation
Time frame: 5 minutes after endotracheal intubation
Standard deviation 1 (SD1) of a Poincaré plot during 5 minutes before surgical incision
Time frame: 5 minutes before surgical incision
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after anesthesia induction
Time frame: 5 minutes after anesthesia induction
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes after endotracheal intubation
Time frame: 5 minutes after endotracheal intubation
Standard deviation 2 (SD2) of a Poincaré plot during 5 minutes before surgical incision
Time frame: 5 minutes before surgical incision
Mean arterial blood pressure during 5 minutes before anesthesia induction
Time frame: 5 minutes before anesthesia induction
Mean arterial 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
Time frame: 5 minutes after endotracheal intubation
Mean arterial blood pressure during 5 minutes before surgical incision
Time frame: 5 minutes before surgical incision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonghae Kim, M.D. principal investigator
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anesthesia induction with propofol and Anesthesia induction with remimazolam in people with General Anesthetics, run by Daegu Catholic University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Between 5 minutes before and after anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.