Trial | NCT03961958  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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.
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 Started
Jul 31
2009
Primary Completion
Jan 31
2014
Study Completion
Jan 31
2014
Last Update
May 23
2019

Drug Propofol reduction

Reduction of propofol target concentration

No protocolled propofol reduction No Intervention

In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60.

Two protocolled propofol reductions Experimental

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

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
No Results Posted