Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning

May 22, 2019 updated by: Daniela Chalo, University of Salamanca

Relationship Between Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning in Propofol TCI Guided Anesthesia

Induction of anesthesia and the knee-chest position are associated with hemodynamic changes that may impact patient outcomes.

Changes from baseline in cardiac output and other hemodynamic variables following induction of anesthesia and knee-chest positioning were compared. Propofol plasma concentrations were also measured after induction of anesthesia and after the knee-chest position.

The aim of this study was to assess whether planned reductions in target-controlled infusion propofol concentrations attenuate the hemodynamic changes associated with anesthesia induction and knee-chest position.

The secondary aim was to quantify the variation in propofol measured plasma concentrations (Cm), both after induction and after KC positioning, and correlate them with predicted concentrations (Cp) by the Schnider Pk model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 20 patients scheduled for elective lumbar spinal surgery in the knee-chest position were included. In addition to standard anesthesia monitoring, bispectral index and noninvasive cardiac output monitoring were undertaken. The study was carried out in 2 parts. In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness: reduction calculated using a predefined formula, and (2) before positioning: reduction equal to the average percentage decrease in CO after knee-chest position in phase 1.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal
        • Centro Hospitalar do Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Lumbar spinal condition for surgical treatment in knee-chest position

Exclusion Criteria:

  • Severe ischemic heart disease
  • Congestive heart failure
  • Atrial fibrillation or flutter
  • Body mass index > 35 kg/m2
  • Glasgow Coma Scale < 15
  • Dementia disease
  • History of drug abuse or addiction
  • Consumption of opioid medication
  • Pre-operative administration of midazolam

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No protocolled propofol reduction
In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60.
Experimental: Two protocolled propofol reductions
In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness-reduction calculated using a predefined formula, and (2) before positioning-reduction equal to the average percentage decrease in CO after knee-chest position in phase
Drug: Propofol reduction
Reduction of propofol target concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic changes
Time Frame: Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)
Changes from baseline in cardiac output and comparison of the changes between both groups.
Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic changes
Time Frame: Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)
Correlation between propofol measured plasma concentrations and predicted plasma concentrations (Cp) by the Schnider Pk model.
Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Collaborators

Centro Hospitalar do Porto

Investigators

  • Study Director: Consuelo S Sanchez, PhD, University of Salamanca, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 11, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USalamanca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication will be shared

IPD Sharing Time Frame

starting 6 months from publication, for 1 year

IPD Sharing Access Criteria

everyone who asks for access after the explanation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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