Influence of Age, Sepsis and SLCO1A2 Polymorphisms on Rocuronium Pharmacokinetics

Summary

This study aims to evaluate the influence of age and sepsis on in vivo activity of OATP1A2 using rocuronium (ROC) as a probe and evaluating the pharmacokinetics and pharmacodynamics in ASA I-III surgical patients. Thus, adult patients without sepsis (control group, n= 12), adult patients with sepsis (sepsis group, n= 12) and elderly patients without sepsis (elderly group, n= 12), all submitted to small to medium-sized surgeries who were induced with individual doses of rocuronium, fentanyl and propofol are being investigated.

Conditions

• Sepsis
• Systemic Inflammatory Response Syndrome
• Septic Shock

Interventions

PROCEDURE

Serial blood sampling

Serial blood samples are being collected at times 0, 2, 5, 10, 15, 20, 30, 60, 120, 180, 240 and 360 minutes after rocuronium administration.

PROCEDURE

Train of four monitoring

Neuromuscular blockade is being evaluated at the same time of blood sampling by stimulation of the adductor muscle of the thumb on the ulnar nerve through the train of four monitoring (TOF).

PROCEDURE

Blood testing for liver and renal function

Blood testing: urea, creatinine, aspartate aminotransferase, alanine aminotransferase, albumin, glycemia

DRUG

General anesthesia

All patients were induced with individual intravenous doses of midazolam, rocuronium, fentanyl and propofol.

PROCEDURE

Small to medium sized surgery under general anesthesia

Patients classified according American Society of Anesthesiologists (ASA) as ASA I-III and submitted to small-medium sized surgery under general anesthesia were recruited for the present investigation.

Sponsors & Collaborators

• University of Sao Paulo

  collaborator OTHER

• Universidade Estadual Paulista Júlio de Mesquita Filho

  lead OTHER

Principal Investigators

• Natalia V. de Moraes, Prof. · Universidade Estadual Paulista Júlio de Mesquita Filho

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Brazil

Study Locations