Anesthesia; ReactionNCT03072069
Analysis of Autonomic Function During Anesthesia Using Response Surface Model
An observational study of Anesthesia; Reaction and Autonomic Imbalance, run by National Central University at 1 site in Taiwan.
Trial summary
Anesthesia in the modern age is at least a two-drug process consisting of an opioid and a sedative hypnotic (e.g., fentanyl and propofol in combination, among others). Therefore, it is important to understand the interaction pharmacodynamics of these agents as they are used clinically. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia; Reaction, Autonomic Imbalance
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Feb 2017to 21 Feb 2018
- 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: A prospective, observational, non-randomized study was conducted in 30 patients with American Society of Anaesthesiologists (ASA) physical status I who underwent elective surgery. Participants ages ranged from 20 to 60 years. Exclusion criteria were recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function. No sedative or opioid drugs were administered before induction of anaesthesia.
Who may be able to join
- American Society of Anaesthesiologists (ASA) physical status I who underwent elective surgery.
Who cannot join
- recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function. No sedative or opioid drugs were administered before induction of anaesthesia.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Surgery, Hsin-chu Branch, Taipei Veterans General Hospital, Taiwan
Hsinchu, 320
About this study
Anesthesia in the modern age is at least a two-drug process consisting of an opioid and a sedative hypnotic (e.g., fentanyl and propofol in combination, among others). Therefore, it is important to understand the interaction pharmacodynamics of these agents as they are used clinically. A good method for visualizing the pharmacodynamic interaction behavior of drug combinations is through response surface models. Unlike traditional isobolograms that represent the concentrations of two agents that combine to produce a single degree of drug effect, response surface models characterize the complete spectrum of interaction between two or more agents for all possible levels of concentration and effect. The investigators try to use the response surface model to evaluate the effect of anesthetic combination of autonomic system.
Read the detailed description
Spectral analysis of heart rate variability (HRV) is a widely used, noninvasive technique to assess autonomic indexes of neural cardiac control. 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. The current study used HRV in order to characterize autonomic nerve system (ANS) activity in patients before and during stable hypnosis, nociceptive surgical stimulation and (adequate) or light (inadequate) analgesia. These effects may vary with the anesthetic technique used. Despite these previous studies, attempts to derive the relation between anesthetic concentrations and HRV have so far remained inconclusive. Such characterization would provide additional information on the behavior of the ANS during different anesthesic drug level and may lay the basis for the development of new clinical application.
Propofol is now widely used in clinical practice because of its favorable recovery profile and low incidence of side effects. However, induction of anesthesia with propofol is often associated with a significant decrease in arterial blood pressure and heart rate (HR). The hypotensive effect of propofol has been attributed to a decrease in systemic vascular resistance or in cardiac output caused by a combination of venous and arterial vasodilation, impaired baroreflex mechanisms and depression of myocardial contractility. Besides, there are some conflicting data regarding the effects of propofol on cardiac sympathetic or parasympathetic tone.
The investigators hypothesis was that at different propofol anesthetic drug level would have reproducible effects on HRV. In addition, these results should be reliably characterized in anesthetized patients provided that HRV uses analysis that can assess transient and rapid changes in ANS activity. Therefore, the first goal of this study was to test the hypothesis that propofol anesthesia would affect HRV depending on the concentrations, and so do opioid and midazolam. Second, the investigators will evaluate the effect of anesthetic combination of autonomic system.
- Conditions
- Anesthesia; Reaction, Autonomic Imbalance
What is being measured
The primary outcome is the main question the study is designed to answer.
change of heart rate variability
propofol anesthesia or combination with other anesthetics would affect HRV depending on the concentrations
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start21 Feb 2017
- Primary completion21 Feb 2018
- Study completion21 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; ReactionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Central University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Yi Wang, National Central University
- Investigators
- Chien-Kun Ting, PhD, Study director, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072069
- Sponsor's protocol ID
- NationalCentralU-RSM
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2017
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: If individual participant data collected in this study are to be made available to other researchers after the end of the study, vital signs and heart rate variability are to be shared, when data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Autonomic Function During Anesthesia Using Response Surface Model
- ClinicalTrials.gov ID
- NCT03072069
- Acronym / sponsor ID
- NationalCentralU-RSM
- Conditions
- Anesthesia; Reaction, Autonomic Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Central UniversityUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 7 Mar 2017 (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.
Anesthesia in the modern age is at least a two-drug process consisting of an opioid and a sedative hypnotic (e.g., fentanyl and propofol in combination, among others). Therefore, it is important to understand the interaction pharmacodynamics of these agents as they are used clinically. A good method for visualizing the pharmacodynamic interaction behavior of drug combinations is through response surface models. Unlike traditional isobolograms that represent the concentrations of two agents that combine to produce a single degree of drug effect, response surface models characterize the complete spectrum of interaction between two or more agents for all possible levels of concentration and effect. The investigators try to use the response surface model to evaluate the effect of anesthetic combination of autonomic system.
Detailed description
Spectral analysis of heart rate variability (HRV) is a widely used, noninvasive technique to assess autonomic indexes of neural cardiac control. 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. The current study used HRV in order to characterize autonomic nerve system (ANS) activity in patients before and during stable hypnosis, nociceptive surgical stimulation and (adequate) or light (inadequate) analgesia. These effects may vary with the anesthetic technique used. Despite these previous studies, attempts to derive the relation between anesthetic concentrations and HRV have so far remained inconclusive. Such characterization would provide additional information on the behavior of the ANS during different anesthesic drug level and may lay the basis for the development of new clinical application.
Propofol is now widely used in clinical practice because of its favorable recovery profile and low incidence of side effects. However, induction of anesthesia with propofol is often associated with a significant decrease in arterial blood pressure and heart rate (HR). The hypotensive effect of propofol has been attributed to a decrease in systemic vascular resistance or in cardiac output caused by a combination of venous and arterial vasodilation, impaired baroreflex mechanisms and depression of myocardial contractility. Besides, there are some conflicting data regarding the effects of propofol on cardiac sympathetic or parasympathetic tone.
The investigators hypothesis was that at different propofol anesthetic drug level would have reproducible effects on HRV. In addition, these results should be reliably characterized in anesthetized patients provided that HRV uses analysis that can assess transient and rapid changes in ANS activity. Therefore, the first goal of this study was to test the hypothesis that propofol anesthesia would affect HRV depending on the concentrations, and so do opioid and midazolam. Second, the investigators will evaluate the effect of anesthetic combination of autonomic system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A prospective, observational, non-randomized study was conducted in 30 patients with American Society of Anaesthesiologists (ASA) physical status I who underwent elective surgery. Participants ages ranged from 20 to 60 years. Exclusion criteria were recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function. No sedative or opioid drugs were administered before induction of anaesthesia.
Key inclusion criteria (1 listed)
- American Society of Anaesthesiologists (ASA) physical status I who underwent elective surgery.
Key exclusion criteria (1 listed)
- recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function. No sedative or opioid drugs were administered before induction of anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of heart rate variability
Time frame: up to 24 weeks
propofol anesthesia or combination with other anesthetics would affect HRV depending on the concentrations
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 28 Feb 2019.
- Individual participant dataSharing planned: Undecided. If individual participant data collected in this study are to be made available to other researchers after the end of the study, vital signs and heart rate variability are to be shared, when data will be available.
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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.
Chien-Kun Ting, PhD study director
National Yang Ming Chiao Tung University
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 Anesthesia; Reaction and Autonomic 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 28 Feb 2019. 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?
change of heart rate variability (time frame: up to 24 weeks). 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 28 Feb 2019.