Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT03961958
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2019-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning
Sponsor:
University of Salamanca
Organization:
Study Overview
Official Title:
Relationship Between Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning in Propofol TCI Guided Anesthesia
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: