Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_4 sepsis

Timeline

Completed

Started Feb 2014

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

February 1, 2014

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed

24 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

Last Updated

January 25, 2017

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

March 2, 2015

Last Update Submit

January 24, 2017

Conditions

Sepsis Systemic Inflammatory Response Syndrome Septic Shock

Outcome Measures

Primary Outcomes (1)

Determination of AUC/dose
Determination of area under the plasma concentration versus time curve (AUC)/dose of rocuronium will be estimated for pharmacokinetic analysis.
Up to 6h after rocuronium administration

Secondary Outcomes (9)

Determination of total clearance
Up to 6h after rocuronium administration
Determination of volume of distribution
Up to 6h after rocuronium administration
Determination of mean residence time
Up to 6h after rocuronium administration
OATP1A2 genotyping using Real Time-PCR
Up to 5 minutes before rocuronium administration
Analysis of cytokine IL-1α in plasma
Up to 5 minutes before rocuronium administration; 30 and 360 minutes after rocuronium administration
+4 more secondary outcomes

Study Arms (3)

Control group

ACTIVE COMPARATOR

Adult patients(18-50 years old) ASA I-II without sepsis submitted to small to medium sized surgery under general anesthesia are being recruited. All patients are being induced with individualized doses of rocuronium, midazolam, propofol and fentanyl. Serial blood sampling are being collected up to 6 h after administration of the drug for pharmacokinetic study. Neuromuscular blockade is being monitored by stimulation of the adductor muscle of the thumb on the ulnar nerve through the train of four monitoring (TOF) at the same time as blood sampling. All patients are being submitted to blood testing for liver and renal function (creatinine, urea, albumin, aspartate aminotransferase and alanine aminotransferase).

Procedure: Serial blood samplingProcedure: Train of four monitoringProcedure: Blood testing for liver and renal functionDrug: General anesthesiaProcedure: Small to medium sized surgery under general anesthesia

Sepsis group

EXPERIMENTAL

Adult patients (18-50 years old) ASAII and III with sepsis, systemic inflammatory response syndrome or septic shock submitted to small to medium sized surgery under general anesthesia are being recruited. All patients are being induced with individualized doses of rocuronium, midazolam, propofol and fentanyl. Serial blood sampling are being collected up to 6 h after administration of the drug for pharmacokinetic study. Neuromuscular blockade is being monitored by stimulation of the adductor muscle of the thumb on the ulnar nerve through the train of four monitoring (TOF) at the same time as blood sampling. All patients are being submitted to blood testing for liver and renal function (creatinine, urea, albumin, aspartate aminotransferase and alanine aminotransferase).

Elderly group

EXPERIMENTAL

Elderly patients (\> 65 years old) ASA I-II without sepsis submitted to small to medium sized surgery under general anesthesia are being recruited. All patients are being induced with individualized doses of rocuronium, midazolam, propofol and fentanyl. Serial blood sampling are being collected up to 6 h after administration of the drug for pharmacokinetic study. Neuromuscular blockade is being monitored by stimulation of the adductor muscle of the thumb on the ulnar nerve through the train of four monitoring (TOF) at the same time as blood sampling. All patients are being submitted to blood testing for liver and renal function (creatinine, urea, albumin, aspartate aminotransferase and alanine aminotransferase).

Interventions

Serial blood samplingPROCEDURE

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.