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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03961958
Enrollment
20
Registered
2019-05-23
Start date
2009-07-31
Completion date
2014-01-31
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Hemodynamic Instability, Surgery

Keywords

Hemodynamics, Knee-Chest Position, Propofol, Anesthesia, General, Anesthetics, Intravenous, pharmacokinetics

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.

Interventions

DRUGPropofol reduction

Reduction of propofol target concentration

Sponsors

Centro Hospitalar do Porto
CollaboratorOTHER
University of Salamanca
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamic changesBaseline (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

MeasureTime frameDescription
Pharmacokinetic changesBaseline (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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026