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

NCT03961958 | Completed

• 1 other identifier: USalamanca
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability; Anesthesia; Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacokinetic changes

  Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)

Study Arms (2)

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

Drug: Propofol reduction

Interventions

Propofol reduction DRUG

Reduction of propofol target concentration

Two protocolled propofol reductions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lumbar spinal condition for surgical treatment in knee-chest position

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead
• Centro Hospitalar do Porto: collaborator

Study Sites (1)

Centro Hospitalar do Porto

Porto, Portugal

Location

Study Officials

• Consuelo S Sanchez, PhD

  University of Salamanca, Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: May 11, 2019
• First Posted: May 23, 2019
• Study Start: July 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: starting 6 months from publication, for 1 year
• Access Criteria: everyone who asks for access after the explanation

Locations

PT (1)