Influence of Age, Sepsis and SLCO1A2 Polymorphisms on Rocuronium Pharmacokinetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Healthy Volunteers

NCT00321360

Healthy

COMPLETED PHASE4

Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

NCT00757458

Drug Contamination

UNKNOWN NA

Observation of Propofol Titration at Different Speeds

NCT04595591

Anesthesia, General Hemodynamics

COMPLETED NA

Pharmacokinetics and Pharmacodynamics of Rocuronium in Closed-Loop Infusion System

NCT02364934

TOF Sex

UNKNOWN

Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection

NCT03422315

General Anesthesia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Rocuronium (ROC), a neuromuscular blocking agent used in surgical procedures, is primarily eliminated by biliary excretion. Its distribution to the liver, mediated the organic anion transporting polypeptide 1A2 (OATP1A2), is a determining factor for the duration of neuromuscular blockade. Age and release of cytokines during inflammation and infection processes of sepsis can alter expression of SLCO1A2 gene, encoding OATP1A2. The objective of this study is to evaluate the influence of age and sepsis on in vivo activity of OATP1A2 using ROC as a probe and evaluating the pharmacokinetics and pharmacodynamics in ASA I-III surgical patients. 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 are being investigated. All patients are being induced with individual doses of rocuronium, fentanyl and propofol. Serial blood samples are being collected up to 360 minutes after administration of ROC. Neuromuscular blockade induced by ROC is monitored by stimulation of the adductor muscle of the thumb on the ulnar nerve through the train of four monitoring (TOF) at the same times of blood sampling. The plasma concentration of ROC will be analyzed by liquid chromatography coupled to mass spectrometry with electrospray ionization using positive ion mode.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis Systemic Inflammatory Response Syndrome Septic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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).

Group Type ACTIVE_COMPARATOR

Serial blood sampling

Intervention Type PROCEDURE

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.

Train of four monitoring

Intervention Type PROCEDURE

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).

Blood testing for liver and renal function

Intervention Type PROCEDURE

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

General anesthesia

Intervention Type DRUG

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

Small to medium sized surgery under general anesthesia

Intervention Type PROCEDURE

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.

Sepsis group

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).

Group Type EXPERIMENTAL

Serial blood sampling

Intervention Type PROCEDURE

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.

Train of four monitoring

Intervention Type PROCEDURE

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).

Blood testing for liver and renal function

Intervention Type PROCEDURE

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

General anesthesia

Intervention Type DRUG

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

Small to medium sized surgery under general anesthesia

Intervention Type PROCEDURE

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.

Elderly group

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).

Group Type EXPERIMENTAL

Serial blood sampling

Intervention Type PROCEDURE

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.

Train of four monitoring

Intervention Type PROCEDURE

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).

Blood testing for liver and renal function

Intervention Type PROCEDURE

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

General anesthesia

Intervention Type DRUG

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

Small to medium sized surgery under general anesthesia

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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).

Intervention Type PROCEDURE

Blood testing for liver and renal function

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

Intervention Type PROCEDURE

General anesthesia

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TOF Midazolam Rocuronium Fentanyl Propofol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult and elderly patients, both gender.
* Patients submitted to small to medium-sized surgeries.
* Patients who were induced with individual doses of rocuronium, fentanyl and propofol.
* Patients with normal renal function (creatinine clearance \> 60 mL/min).
* Patients with normal liver function.

Exclusion Criteria

* Patients who were in use of fluoxetine, carbamazepine, aminoglycoside antibiotics, OATP1A2 inhibitors.
* Patients with gastrointestinal and liver diseases, neuromuscular disorders.
* Patients who were in chronic use of drugs which alter rocuronium effect.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No