Participants Scheduled for Surgery Under Spinal Anesthesia Without Impairment of Renal, Hepatic, Cardiac or Respiratory FunctionNCT04275375
Autonomic Modulation After Spinal Anesthesia With Depth of Anesthesia and Vital Signs.
An observational study of Participants Scheduled for Surgery Under Spinal Anesthesia Without Impairment of Renal, Hepatic, Cardiac or Respiratory Function, run by National Central University at 1 site in Taiwan.
Trial summary
Spinal anaesthesia has the advantage that produced nerve block by the injection of local anaesthetic into cerebrospinal fluid (CSF). However, the greatest challenge in spinal anaesthesia is to control the spread of local anaesthetic through the CSF to provide a block which is adequate for the proposed surgery without… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Participants Scheduled for Surgery Under Spinal Anesthesia Without Impairment of Renal, Hepatic, Cardiac or Respiratory Function
- What is being tested?
- observation study about the autonomic response after spinal anesthesia
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 16 Aug 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators conducted a prospective observational study on patients who were scheduled to undergo elective surgery and spinal anesthesia. The investigators excluded patients who had recently been treated with a sedative, beta-blocker, parasympatholytic, or opioid agent, patients who had undergone emergency surgery, those with hypovolemia and hypothermia, arrhythmia, diabetes, or impairment of renal, hepatic, coagulation, cardiac, or respiratory function
Who may be able to join
- 1. patients scheduled for operation with spinal anesthesia
Who cannot join
- recently treat with a sedative, beta-blocker, parasympatholytic, or opioid agent
- emergency surgery
- hypovolemia and hypothermia, arrhythmia, diabetes, or impairment of renal, hepatic, coagulation, cardiac, or respiratory function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Anaesthesiology, Taipei Veterans General Hospita, Taipei, Taiwan
Spinal anaesthesia has the advantage that produced nerve block by the injection of local anaesthetic into cerebrospinal fluid (CSF). However, the greatest challenge in spinal anaesthesia is to control the spread of local anaesthetic through the CSF to provide a block which is adequate for the proposed surgery without unnecessary extensive spread, and increased risk of complications.
Read the detailed description
The activity of the autonomic nervous system is of fundamental importance in the regulation of vital bodily functions. Unbalance of autonomic nerve system results in considerably disordered vital function. Clinically, this is of great significance, because if an anesthetic agent produces cause the sympathetic system to block, the effects can be serious in individual cases, particularly on the cardiovascular system. If complications are to be avoided, it is essential to assess the degree of block correctly. Clinical monitoring has a variety of applications, a particularly useful one being measurement of the sympathetic system during regional anesthesia, for which quantification of the blocking effect is a clinical necessity and the degree of block needs to be ascertained without delay. The autonomic nervous system (ANS) plays an important role in the regulation of hemodynamics during anesthesia. Analysis of beat-to-beat fluctuations of heart rate and blood pressure is a promising new approach to the clinical diagnosis and management of alterations in cardiovascular regulation. Continuous Wavelet Transform (CWT), which could overcome the limitation of the steady-state assumption in the classical spectral analysis, is believed as a reliable and robust method to access cardiorespiratory dynamics of the ANS and the investigators will applied during spinal anesthesia to evaluate the detail changes.
- Being tested
- observation study about the autonomic response after spinal anesthesia
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation study about the autonomic response after spinal anesthesiaOther
ECG waveforms were continuously recorded using a multichannel polygraphic system (Embla N7000, Natus, Pleasanton, CA). The data were saved at a rate of 1024 Hz directly to a memory card within the device for offline analysis of heart rate variability (HRV) and PPG. All data included in the analysis were obtained from continuous artifact-free ECG recordings for analysis of the immediate effects of spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric bupivacaine | The dosage of hyperbaric bupivacaine decided by the clinical anesthesiologist. This study is an observational study. Receives: Other: observation study about the autonomic response after spinal anesthesia | |
| plain bupivacaine | The dosage of plain bupivacaine decided by the clinical anesthesiologist. This study is an observational study. Receives: Other: observation study about the autonomic response after spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
record and compare changes in ANS function( HRV and PPGA) after spinal anesthesia in different group
Electrocardiography and pulse photoplethysmography signals were recorded after spinal anesthesia. The spectrogram of beat-to-beat R-to-R intervals was derived by continuous wavelet transform (CWT), and the immediate power of high frequency (HFi) and low frequency (LFi) bands was extracted at
1-second intervals. The derived parameters, HF, LF, and pulse photoplethysmography amplitude, were normalized by their maximum and minimum values. Mixed-model regression and repeated-measures analysis of variance were used to explore the time-dependent effect.
Measured: maximum for 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Mar 2019
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants Scheduled for Surgery Under Spinal Anesthesia Without Impairment of Renal, Hepatic, Cardiac or Respiratory FunctionStudies 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
- 46 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275375
- Sponsor's protocol ID
- 2019-01-016CC
- Status last verified
- Jul 2022
- First submitted
- 12 Feb 2020
- Last updated
- 28 Jul 2022
- 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 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anaesthesiology, Taipei Veterans General Hospita, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT04275375
- Acronym / sponsor ID
- 2019-01-016CC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Central UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 19 Feb 2020 (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.
Spinal anaesthesia has the advantage that produced nerve block by the injection of local anaesthetic into cerebrospinal fluid (CSF). However, the greatest challenge in spinal anaesthesia is to control the spread of local anaesthetic through the CSF to provide a block which is adequate for the proposed surgery without unnecessary extensive spread, and increased risk of complications.
Detailed description
The activity of the autonomic nervous system is of fundamental importance in the regulation of vital bodily functions. Unbalance of autonomic nerve system results in considerably disordered vital function. Clinically, this is of great significance, because if an anesthetic agent produces cause the sympathetic system to block, the effects can be serious in individual cases, particularly on the cardiovascular system. If complications are to be avoided, it is essential to assess the degree of block correctly. Clinical monitoring has a variety of applications, a particularly useful one being measurement of the sympathetic system during regional anesthesia, for which quantification of the blocking effect is a clinical necessity and the degree of block needs to be ascertained without delay. The autonomic nervous system (ANS) plays an important role in the regulation of hemodynamics during anesthesia. Analysis of beat-to-beat fluctuations of heart rate and blood pressure is a promising new approach to the clinical diagnosis and management of alterations in cardiovascular regulation. Continuous Wavelet Transform (CWT), which could overcome the limitation of the steady-state assumption in the classical spectral analysis, is believed as a reliable and robust method to access cardiorespiratory dynamics of the ANS and the investigators will applied during spinal anesthesia to evaluate the detail changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric bupivacaine | – | Other: observation study about the autonomic response after spinal anesthesiaThe dosage of hyperbaric bupivacaine decided by the clinical anesthesiologist. This study is an observational study. |
| plain bupivacaine | – | Other: observation study about the autonomic response after spinal anesthesiaThe dosage of plain bupivacaine decided by the clinical anesthesiologist. This study is an observational study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators conducted a prospective observational study on patients who were scheduled to undergo elective surgery and spinal anesthesia. The investigators excluded patients who had recently been treated with a sedative, beta-blocker, parasympatholytic, or opioid agent, patients who had undergone emergency surgery, those with hypovolemia and hypothermia, arrhythmia, diabetes, or impairment of renal, hepatic, coagulation, cardiac, or respiratory function
Key inclusion criteria (1 listed)
- 1. patients scheduled for operation with spinal anesthesia
Key exclusion criteria (3 listed)
- recently treat with a sedative, beta-blocker, parasympatholytic, or opioid agent
- emergency surgery
- hypovolemia and hypothermia, arrhythmia, diabetes, or impairment of renal, hepatic, coagulation, 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 study about the autonomic response after spinal anesthesiaECG waveforms were continuously recorded using a multichannel polygraphic system (Embla N7000, Natus, Pleasanton, CA). The data were saved at a rate of 1024 Hz directly to a memory card within the device for offline analysis of heart rate variability (HRV) and PPG. All data included in the analysis were obtained from continuous artifact-free ECG recordings for analysis of the immediate effects of spinal anesthesia. | Other | hyperbaric bupivacaine, plain bupivacaine |
Primary outcome
record and compare changes in ANS function( HRV and PPGA) after spinal anesthesia in different group
Time frame: maximum for 4 hours
Electrocardiography and pulse photoplethysmography signals were recorded after spinal anesthesia. The spectrogram of beat-to-beat R-to-R intervals was derived by continuous wavelet transform (CWT), and the immediate power of high frequency (HFi) and low frequency (LFi) bands was extracted at 1-second intervals. The derived parameters, HF, LF, and pulse photoplethysmography amplitude, were normalized by their maximum and minimum values. Mixed-model regression and repeated-measures analysis of variance were used to explore the time-dependent effect.
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 Jul 2022.
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 Participants Scheduled for Surgery Under Spinal Anesthesia Without Impairment of Renal, Hepatic, Cardiac or Respiratory Function, 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 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 28 Jul 2022. 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?
record and compare changes in ANS function( HRV and PPGA) after spinal anesthesia in different group (time frame: maximum for 4 hours). 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 Jul 2022.