Autonomic Nervous System ImbalanceNCT03613961
Effects of Propofol Induction Anaesthesia on the Heart Rate Variability
An observational study of Autonomic Nervous System Imbalance, run by National Central University at 1 site in Taiwan.
Trial summary
The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Autonomic Nervous System Imbalance
- What is being tested?
- Anesthetics
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jul 2017to 1 Jul 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: patients scheduled for surgery under general anesthesia.
Who may be able to join
- The subjects were selected from patients scheduled for surgery under general anesthesia.
Who cannot join
- recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Effects of Propofol Induction Anaesthesia on the Heart Rate Variability Dynamics
The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration.
Read the detailed description
Because the ANS, especially the sympathetic nervous system, plays a major role in regulating cardiovascular homeostasis, knowledge of how anesthetic agents modify sympathetic activity is important for understanding subsequent cardiovascular responses.
Spectral analysis of heart rate variability (HRV) is a promising new approach, widely used, noninvasive technique to assess the autonomic indexes of neural cardiac control and has been correlated to the integrity and balance of the sympathetic and parasympathetic activation status. The presence of low-frequency (LF) and high-frequency (HF) oscillatory rhythms in the variability of the R-R interval (RRI) is well established. To date, it is believed that LF is mediated by the parasympathetic and sympathetic systems, whereas HF is mediated primarily by the parasympathetic system. There has been a lot of methodological analysis developed to evaluate the ANS function during anesthesia. In this study, Continuous Wavelet Transform (CWT), believed as a reliable and robust method to access cardiorespiratory dynamics of the ANS due to its adaptability and adjustability between spectral and temporal scale using a window of variable width, was used as a method for analyzing dynamic cardiovascular signals during anesthesia.
- Conditions
- Autonomic Nervous System Imbalance
- Being tested
- Anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnestheticsDrug
The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration. We will observe the relationship of anesthetics and HRV dynamics.
What is being measured
The primary outcome is the main question the study is designed to answer.
HRV dynamics
Evaluate the changes in heart rate variability at different propofol concentration
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start25 Jul 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous System ImbalanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Central University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Yi Wang, National Central University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613961
- Sponsor's protocol ID
- VGHTPE
- Status last verified
- Jan 2020
- First submitted
- 29 Jul 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: all collected IPD, that underlie results in a publication
Publications
Wang HY, Lo MT, Chen KH, Mandell S, Chang WK, Lin C, Ting CK. Strong Early Phase Parasympathetic Inhibition Followed by Sympathetic Withdrawal During Propofol Induction: Temporal Response Assessed by Wavelet-Based Spectral Analysis and Photoplethysmography. Front Physiol. 2021 Sep 13;12:705153. doi: 10.3389/fphys.2021.705153. eCollection 2021.
PubMed 34588990
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Propofol Induction Anaesthesia on the Heart Rate Variability Dynamics
- ClinicalTrials.gov ID
- NCT03613961
- Acronym / sponsor ID
- VGHTPE
- Conditions
- Autonomic Nervous System Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Central UniversityUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 3 Aug 2018 (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 ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration.
Detailed description
Because the ANS, especially the sympathetic nervous system, plays a major role in regulating cardiovascular homeostasis, knowledge of how anesthetic agents modify sympathetic activity is important for understanding subsequent cardiovascular responses.
Spectral analysis of heart rate variability (HRV) is a promising new approach, widely used, noninvasive technique to assess the autonomic indexes of neural cardiac control and has been correlated to the integrity and balance of the sympathetic and parasympathetic activation status. The presence of low-frequency (LF) and high-frequency (HF) oscillatory rhythms in the variability of the R-R interval (RRI) is well established. To date, it is believed that LF is mediated by the parasympathetic and sympathetic systems, whereas HF is mediated primarily by the parasympathetic system. There has been a lot of methodological analysis developed to evaluate the ANS function during anesthesia. In this study, Continuous Wavelet Transform (CWT), believed as a reliable and robust method to access cardiorespiratory dynamics of the ANS due to its adaptability and adjustability between spectral and temporal scale using a window of variable width, was used as a method for analyzing dynamic cardiovascular signals during anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients scheduled for surgery under general anesthesia.
Key inclusion criteria (1 listed)
- The subjects were selected from patients scheduled for surgery under general anesthesia.
Key exclusion criteria (1 listed)
- recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function.
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 |
|---|---|---|
| AnestheticsThe ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration. We will observe the relationship of anesthetics and HRV dynamics. | Drug | – |
Primary outcome
HRV dynamics
Time frame: 2 minutes
Evaluate the changes in heart rate variability at different propofol concentration
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 9 Jan 2020.
- Derived from this study: PubMed 34588990Wang HY, Lo MT, Chen KH, Mandell S, Chang WK, Lin C, Ting CK. Strong Early Phase Parasympathetic Inhibition Followed by Sympathetic Withdrawal During Propofol Induction: Temporal Response Assessed by Wavelet-Based Spectral Analysis and Photoplethysmography. Front Physiol. 2021 Sep 13;12:705153. doi: 10.3389/fphys.2021.705153. eCollection 2021.
- Individual participant dataSharing planned: No. all collected IPD, that underlie results in a publication
Related trials for Autonomic Nervous System Imbalance
Enrolling by invitationObservational study
Non-Invasive Bioelectronic Analytics
Autonomic Dysfunction, Autonomic Imbalance
Recruiting
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
Septic Shock
Recruiting
Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome
Functional Gastrointestinal Disorders, Hypermobile Ehlers-Danlos Syndrome
RecruitingObservational study
Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
Colitis, Ulcerative, Sleep Quality
Enrolling by invitationObservational study
Exercise Prescription in Cardiac Rehabilitation Mediated by Autonomic Function
Cardiac Rehabilitation, Exercise Therapy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Nervous System Imbalance, run by National Central University at 1 site in Taiwan.
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 1 inclusion and 1 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 9 Jan 2020. 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 Taiwan. 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.
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?
HRV dynamics (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03613961, which also lists 1 linked publication.
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 9 Jan 2020.