Autonomic Modulation After Propofol Target Controlled Infusion and Bolus Administration

NCT ID: NCT03954262

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2019-12-31

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.

Conditions

Anesthesia; Autonomic Imbalance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TCI group

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

observation of propofol ANS response

Intervention Type: BEHAVIORAL

received an induction bolus or TCI infusion of propofol

bolus group

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

observation of propofol ANS response

Intervention Type: BEHAVIORAL

received an induction bolus or TCI infusion of propofol

Interventions

observation of propofol ANS response

received an induction bolus or TCI infusion of propofol

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Central University

OTHER

Sponsor Role: lead

Responsible Party

Hsin-Yi Wang

Taipei Veterans General Hospital, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Veterans General Hospital

Taipei, R.o.c, Taiwan

Taipei Veterans General Hospital, Taiwan

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2019-03-003CC

Identifier Type: -

Identifier Source: org_study_id