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

University of Salamanca

Status: Completed

Conditions: Hemodynamic Instability; Surgery; Anesthesia

Treatments: Drug: Propofol reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03961958

USalamanca

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

No protocolled propofol reduction

No Intervention group

Description:

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

Two protocolled propofol reductions

Experimental group

Description:

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

Treatment:

Drug: Propofol reduction