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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961958
• Other study ID #: USalamanca
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: January 2014

Study information

• Verified date: May 2019
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Hemodynamic Instability
• Surgery

Intervention

Drug:
• Propofol reduction
Reduction of propofol target concentration

Locations

Country	Name	City	State
Portugal	Centro Hospitalar do Porto	Porto

Sponsors (2)

Lead Sponsor	Collaborator
University of Salamanca	Centro Hospitalar do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic changes	Changes from baseline in cardiac output and comparison of the changes between both groups.	Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)
Secondary	Pharmacokinetic changes	Correlation between propofol measured plasma concentrations and predicted plasma concentrations (Cp) by the Schnider Pk model.	Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)