AnesthesiaNCT03954262
Autonomic Modulation After Propofol Target Controlled Infusion and Bolus Administration
An observational study of Anesthesia and Autonomic Imbalance, run by National Central University at 2 sites in Taiwan.
Trial summary
Some studies have compared the clinical profile during propofol induction anesthesia with Target-controlled infusion (TCI) and manually bolus showed similar control of anesthesia, such as depth of anaesthesia and hemodynamic stability, but did not use an objective measure of instantaneous autonomic activity during the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia, Autonomic Imbalance
- What is being tested?
- observation of propofol ANS response
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 25 Mar 2019to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects were selected from patients scheduled for surgery under general anesthesia. 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
- patients scheduled for surgery under general anesthesia
Who cannot join
- recent administration of sedative or opioid drugs
- emergency surgery
- impairment of renal, hepatic, cardiac or respiratory function
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Veterans General Hospital
Taipei, R.o.c, 11217
Taipei Veterans General Hospital, Taiwan
Taipei, 112
About this study
Official title: Evaluation of Autonomic Modulation After Propofol Induction Anesthesia With Target Controlled Infusion and Manually Bolus
Some studies have compared the clinical profile during propofol induction anesthesia with Target-controlled infusion (TCI) and manually bolus showed similar control of anesthesia, such as depth of anaesthesia and hemodynamic stability, but did not use an objective measure of instantaneous autonomic activity during the brief time of induction anesthesia. In this study, TCI and manually bolus of propofol injection techniques during induction were studied with wavelet-based spectral analysis and the amplitudes of the pulse plethysmographic. The investigators hypothesized that during propofol induction anesthesia, the instantaneous ANS activities was more stable with TCI than traditional manually bolus
Read the detailed description
Propofol induction anesthesia has been reported to be associated with cardiovascular depression and autonomic nervous system (ANS), which is an important neural control system for maintaining cardiovascular stability and plays a major role in regulating cardiovascular homeostasis. There are many methods for the administration induction of propofol, such as a manually bolus or target-controlled infusion (TCI) techniques. TCI devices could rapidly achieve and maintain the desired predicted concentration and is a more satisfactory technique to reduce the incidence of side effects and with the advantage of better hemodynamic control. More precise knowledge of how anesthetic agents modify ANS activity is important for understanding subsequent cardiovascular responses. However, there was no study using validated measurement of ANS index comparing propofol induction anaesthesia with TCI or manually bolus would have different effects on ANS.
- Conditions
- Anesthesia, Autonomic Imbalance
- Being tested
- observation of propofol ANS response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of propofol ANS responseBehavioural
received an induction bolus or TCI infusion of propofol
| Study group | Role | What they receive |
|---|---|---|
| TCI group | Group I received TCI at 5-6 ug/ml target effect concentration (Ce) Receives: Behavioral: observation of propofol ANS response | |
| bolus group | groups II received an induction bolus of propofol (2-2.5mg/kg). Receives: Behavioral: observation of propofol ANS response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of autonomic index with propofol induction-related sympathetic and parasympathetic imbalance- Assessed by continuous wavelet transform
The presented work is aimed at applying instantaneous measures of heart rate variability data, as determined from the frequency domain analysis of the wavelet transform, to provide able to track fast autonomic effects during propofol induction.
Measured: about 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start25 Mar 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 AnesthesiaStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Central University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Yi Wang, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954262
- Sponsor's protocol ID
- 2019-03-003CC
- Status last verified
- Feb 2020
- First submitted
- 15 May 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liou JY, Chen KH, Lin C, Huang HY, Ting CK, Lo MT, Chang WK, Wang HY. Target-controlled infusion achieves smoother autonomic modulation than manual bolus during propofol induction: Evidence from wavelet-based spectral analysis. J Chin Med Assoc. 2026 Apr 1;89(4):312-318. doi: 10.1097/JCMA.0000000000001364. Epub 2026 Mar 6.
PubMed 41787733
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autonomic Modulation After Propofol Induction Anesthesia With Target Controlled Infusion and Manually Bolus
- ClinicalTrials.gov ID
- NCT03954262
- Acronym / sponsor ID
- 2019-03-003CC
- Conditions
- Anesthesia, Autonomic Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Central UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 May 2019 (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.
Some studies have compared the clinical profile during propofol induction anesthesia with Target-controlled infusion (TCI) and manually bolus showed similar control of anesthesia, such as depth of anaesthesia and hemodynamic stability, but did not use an objective measure of instantaneous autonomic activity during the brief time of induction anesthesia. In this study, TCI and manually bolus of propofol injection techniques during induction were studied with wavelet-based spectral analysis and the amplitudes of the pulse plethysmographic. The investigators hypothesized that during propofol induction anesthesia, the instantaneous ANS activities was more stable with TCI than traditional manually bolus
Detailed description
Propofol induction anesthesia has been reported to be associated with cardiovascular depression and autonomic nervous system (ANS), which is an important neural control system for maintaining cardiovascular stability and plays a major role in regulating cardiovascular homeostasis. There are many methods for the administration induction of propofol, such as a manually bolus or target-controlled infusion (TCI) techniques. TCI devices could rapidly achieve and maintain the desired predicted concentration and is a more satisfactory technique to reduce the incidence of side effects and with the advantage of better hemodynamic control. More precise knowledge of how anesthetic agents modify ANS activity is important for understanding subsequent cardiovascular responses. However, there was no study using validated measurement of ANS index comparing propofol induction anaesthesia with TCI or manually bolus would have different effects on ANS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCI group | – | Behavioral: observation of propofol ANS responseGroup I received TCI at 5-6 ug/ml target effect concentration (Ce) |
| bolus group | – | Behavioral: observation of propofol ANS responsegroups II received an induction bolus of propofol (2-2.5mg/kg). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects were selected from patients scheduled for surgery under general anesthesia. 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)
- patients scheduled for surgery under general anesthesia
Key exclusion criteria (3 listed)
- recent administration of sedative or opioid drugs
- emergency surgery
- 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 |
|---|---|---|
| observation of propofol ANS responsereceived an induction bolus or TCI infusion of propofol | Behavioural | TCI group, bolus group |
Primary outcome
Number of autonomic index with propofol induction-related sympathetic and parasympathetic imbalance- Assessed by continuous wavelet transform
Time frame: about 5 minutes
The presented work is aimed at applying instantaneous measures of heart rate variability data, as determined from the frequency domain analysis of the wavelet transform, to provide able to track fast autonomic effects during propofol induction.
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 12 Feb 2020.
- Derived from this study: PubMed 41787733Liou JY, Chen KH, Lin C, Huang HY, Ting CK, Lo MT, Chang WK, Wang HY. Target-controlled infusion achieves smoother autonomic modulation than manual bolus during propofol induction: Evidence from wavelet-based spectral analysis. J Chin Med Assoc. 2026 Apr 1;89(4):312-318. doi: 10.1097/JCMA.0000000000001364. Epub 2026 Mar 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Autonomic Imbalance, run by National Central University at 2 sites 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 3 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of autonomic index with propofol induction-related sympathetic and parasympathetic imbalance- Assessed by continuous wavelet transform (time frame: about 5 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 NCT03954262, 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 12 Feb 2020.