Autonomic Modulation After Propofol Target Controlled Infusion and Bolus Administration

Sponsor

National Central University (Other)

Overall Status

Completed

CT.gov ID

NCT03954262

Collaborator

(none)

Enrollment

Locations

9.2

Actual Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Autonomic Imbalance	Behavioral: observation of propofol ANS response

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.

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 25, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
TCI group Group I received TCI at 5-6 ug/ml target effect concentration (Ce)	Behavioral: observation of propofol ANS response received an induction bolus or TCI infusion of propofol
bolus group groups II received an induction bolus of propofol (2-2.5mg/kg).	Behavioral: observation of propofol ANS response received an induction bolus or TCI infusion of propofol

Arm

Intervention/Treatment

TCI group

Group I received TCI at 5-6 ug/ml target effect concentration (Ce)

Behavioral: observation of propofol ANS response

received an induction bolus or TCI infusion of propofol

bolus group

groups II received an induction bolus of propofol (2-2.5mg/kg).

Behavioral: observation of propofol ANS response

received an induction bolus or TCI infusion of propofol

Outcome Measures

Primary Outcome Measures

Number of autonomic index with propofol induction-related sympathetic and parasympathetic imbalance- Assessed by continuous wavelet transform [about 5 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei	R.o.c	Taiwan	11217
2	Taipei Veterans General Hospital, Taiwan	Taipei		Taiwan	112

Sponsors and Collaborators

National Central University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hsin-Yi Wang, Taipei Veterans General Hospital, Principal Investigator, Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT03954262

Other Study ID Numbers:

2019-03-003CC

First Posted:

May 17, 2019

Last Update Posted:

Feb 12, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Feb 12, 2020