- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275375
Autonomic Modulation After Spinal Anesthesia With Depth of Anesthesia and Vital Signs.
Department of Anaesthesiology, Taipei Veterans General Hospita, Taipei, Taiwan
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
R.o.c
-
Taipei, R.o.c, Taiwan, 11217
- Taipei Veterans General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1. patients scheduled for operation with spinal anesthesia
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
hyperbaric bupivacaine
The dosage of hyperbaric bupivacaine decided by the clinical anesthesiologist.
This study is an observational study.
|
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.
|
plain bupivacaine
The dosage of plain bupivacaine decided by the clinical anesthesiologist.
This study is an observational study.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
maximum for 4 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-01-016CC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on observation study about the autonomic response after spinal anesthesia
-
Europainclinics z.ú.University Hospital Bratislava; Slovak Academy of Sciences; R-CLINIC s.r.o.; Faculty...Recruiting
-
Assistance Publique - Hôpitaux de ParisCompletedMultiple Sclerosis | HIV | Solid Organ Transplant | Autoimmune or Autoinflammatory Diseases | Solid Tumors or CancersFrance
-
Makassed General HospitalRecruitingCombined Lumbosacral Nerve Block Versus Spinal Anesthesia for Cognitive Function After Hip ProthesisCognitive DeclineLebanon
-
Hebei Medical University Third HospitalNot yet recruitingElderly | Anesthesia
-
University Paul Sabatier of ToulouseCompletedArterio-venous FistulaFrance
-
Derince Training and Research HospitalCompleted
-
Second Affiliated Hospital, School of Medicine,...Enrolling by invitation
-
Ataturk UniversityCompletedAnesthesia, Local | Cesarean Section Complications | HypotensionTurkey
-
Universidad de ExtremaduraCompletedPain | Foot Diseases | MetatarsalgiaSpain
-
Mansoura UniversityCompletedHypotension After Spinal AnesthesiaEgypt