Autonomic Modulation After Propofol Target Controlled Infusion and Bolus Administration

Anesthesia Clinical Trial

Official title:

Evaluation of Autonomic Modulation After Propofol Induction Anesthesia With Target Controlled Infusion and Manually Bolus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954262
• Other study ID #: 2019-03-003CC
• Status: Completed
• Start date: March 25, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: National Central University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Autonomic Imbalance

Intervention

Behavioral:
• observation of propofol ANS response
received an induction bolus or TCI infusion of propofol

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei	R.o.c
Taiwan	Taipei Veterans General Hospital, Taiwan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Central University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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