NCT03613961

Brief Summary

The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

July 29, 2018

Last Update Submit

January 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • HRV dynamics

    Evaluate the changes in heart rate variability at different propofol concentration

    2 minutes

Interventions

The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration. We will observe the relationship of anesthetics and HRV dynamics.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients scheduled for surgery under general anesthesia.

You may qualify if:

  • The subjects were selected from patients scheduled for surgery under general anesthesia.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, R.o.c, 11217, Taiwan

Location

Related Publications (1)

  • Wang HY, Lo MT, Chen KH, Mandell S, Chang WK, Lin C, Ting CK. Strong Early Phase Parasympathetic Inhibition Followed by Sympathetic Withdrawal During Propofol Induction: Temporal Response Assessed by Wavelet-Based Spectral Analysis and Photoplethysmography. Front Physiol. 2021 Sep 13;12:705153. doi: 10.3389/fphys.2021.705153. eCollection 2021.

MeSH Terms

Interventions

Anesthetics

Intervention Hierarchy (Ancestors)

Central Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taipei Veterans General hospital, attending doctor of anesthesiology

Study Record Dates

First Submitted

July 29, 2018

First Posted

August 3, 2018

Study Start

July 25, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

all collected IPD, that underlie results in a publication

Locations