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Clinical Trials/NCT03961958
NCT03961958
Completed
Not Applicable

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

University of Salamanca1 site in 1 country20 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Propofol reduction
Conditions
Hemodynamic Instability
Sponsor
University of Salamanca
Enrollment
20
Locations
1
Primary Endpoint
Hemodynamic changes
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
January 2014
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniela Chalo

Principal Investigator

University of Salamanca

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Propofol reduction

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Pharmacokinetic changes(Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2))

Study Sites (1)

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