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出境医 / 临床实验 / Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning

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

Study Description
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.


Condition or disease Intervention/treatment Phase
Hemodynamic Instability Anesthesia Surgery Drug: Propofol reduction Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Relationship Between Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning in Propofol TCI Guided Anesthesia
Actual Study Start Date : July 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
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Portugal
Centro Hospitalar do Porto
Porto, Portugal
Sponsors and Collaborators
University of Salamanca
Centro Hospitalar do Porto
Investigators
Layout table for investigator information
Study Director: Consuelo S Sanchez, PhD University of Salamanca, Faculty of Medicine
Tracking Information
First Submitted Date  ICMJE May 11, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE July 2009
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning
Official Title  ICMJE Relationship Between Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning in Propofol TCI Guided Anesthesia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hemodynamic Instability
  • Anesthesia
  • Surgery
Intervention  ICMJE Drug: Propofol reduction
Reduction of propofol target concentration
Study Arms  ICMJE
  • 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
    Intervention: Drug: Propofol reduction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2019) 		20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961958
Other Study ID Numbers  ICMJE USalamanca
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication will be shared
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: starting 6 months from publication, for 1 year
Access Criteria: everyone who asks for access after the explanation
Responsible Party Daniela Chalo, University of Salamanca
Study Sponsor  ICMJE University of Salamanca
Collaborators  ICMJE Centro Hospitalar do Porto
Investigators  ICMJE
Study Director: Consuelo S Sanchez, PhD University of Salamanca, Faculty of Medicine
PRS Account University of Salamanca
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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