Clinical trial NCT03954262: Autonomic Modulation After Propofol Target Controlled Infusion and Bolus Administration
Official title: Evaluation of Autonomic Modulation After Propofol Induction Anesthesia With Target Controlled Infusion and Manually Bolus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Autonomic Imbalance
Lead sponsor: National Central University
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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

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.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for surgery under general anesthesia

Exclusion Criteria:

* recent administration of sedative or opioid drugs
* emergency surgery
* impairment of renal, hepatic, cardiac or respiratory function

Primary outcomes:
measure: Number of autonomic index with propofol induction-related sympathetic and parasympathetic imbalance- Assessed by continuous wavelet transform
timeFrame: about 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: R.o.c
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital, Taiwan
Study officials:
References: