Autonomic Modulation After Propofol Target Controlled Infusion and Bolus Administration
Evaluation of Autonomic Modulation After Propofol Induction Anesthesia With Target Controlled Infusion and Manually Bolus
1 other identifier
observational
60
1 country
2
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2019
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2019
CompletedFirst Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 12, 2020
February 1, 2020
9 months
May 15, 2019
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
about 5 minutes
Study Arms (2)
TCI group
Group I received TCI at 5-6 ug/ml target effect concentration (Ce)
bolus group
groups II received an induction bolus of propofol (2-2.5mg/kg).
Interventions
received an induction bolus or TCI infusion of propofol
Eligibility Criteria
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.
You may qualify if:
- patients scheduled for surgery under general anesthesia
You may not qualify if:
- recent administration of sedative or opioid drugs
- emergency surgery
- impairment of renal, hepatic, cardiac or respiratory function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Taipei Veterans General Hospital
Taipei, R.o.c, 11217, Taiwan
Taipei Veterans General Hospital, Taiwan
Taipei, 112, Taiwan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Taipei Veterans General Hospital, Principal Investigator
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 17, 2019
Study Start
March 25, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 12, 2020
Record last verified: 2020-02