Pharmacokinetics and Pharmacodynamics of Rocuronium in Closed－Loop Infusion System

Sex Clinical Trial

Official title:

Effect of Different Anesthetics on Pharmacokinetics and Pharmacodynamics of Rocuronium in Closed－Loop Muscle Relaxant Infusion System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02364934
• Other study ID #: IRB014-090-01
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2014
• Last updated: February 24, 2015
• Start date: March 2015
• Est. completion date: January 2018

Study information

• Verified date: February 2015
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To explore and compare the effects of propoful, sevoflurane, and a combination of both on the pharmacokinetics and pharmacodynamics of rocuronium.

To discover and confirm sex differences on the pharmacokinetics and pharmacodynamics of rocuronium.

To evaluate and examine aged people on the pharmacokinetics and pharmacodynamics of rocuronium.

Description:

Rocuronium is a non-depolarizing neuromuscular blocking agent with intermediate duration of action and without significant cumulative properties, suitable for continuous infusion. This study was designed to determine the dose requirements for rocuronium, administered by continuous infusion to maintain a stable 90-99% T1 depression (depression of the first twitch in the train-of-four, TOF) in adult, elderly and different sex patients under sufentanil and propoful, sevoflurane, or propoful + sevoflurane anaesthesia.

Methods Two hundred and ten patients, ASA physical status group I and II undergoing elective surgical procedures were studied. Pateients with neuromuscular and metabolic diseases, morbid obesity or receiving medication known to influence neuromuscular transmission were excluded from the study.

Anaesthesia Patients will be assigned at random to receive propofuol, sevolurane or propoful+sevoflurane anaesthesia. All patients will induced with midazolam, 0.1 mg/kg, sufentnail, 0.5 μg/kg, etomidate, 0.3 mg/kg and rocuronium, 0.6 mg/kg. In the propoful group, anaesthesia will be continued with propoful and sufentanil. The doseage of propotul and sufentanil will be adjusted by the blood pressure and heart rate of the patients. In the sevoflurane group, anaesthesia will be continued with sevoflurane (2%) and sufentanil. The doseage of sufentanil will be adjusted by the blood pressure and heart rate of the patients. The doseage of propoful and sufentanil will be adjusted by the blood pressure and heart rate of the patients.

Heart rate, invasive blood pressure, pulse and core body temperature were monitored throughout the procedure. The core body temperature was main tained between 36°C and 37°C using a warming blanket. Positive pressure ventilation was used to maintain the end-tidal CO2 between 4.5 kPa and 5.5 kPa. The inspired and end-tidal concentrations of carbon dioxide and volatile anaesthestics were monitored by a multigas monitor.

Neuromuscular transmission was monitored by recording the electromyographic (EMG) activity of the adductor pollicis muscle resulting from the supra- maximal stimulation of the ulnar nerve with train-of- four (TOF), 2 Hz for 2 s, applied at 10-s intervals. The ulnar nerve was stimulated through surface electrodes applied at the wrist, using square-wave currents of 0.2 ms duration. Ten minutes were allowed for the stabilization of anaesthesia and the EMG tracing before the intubating dose of rocuronium, 0.6 mg/kg, was given by the anaesthesiologist.

Rocuronium infusion A personal computer, working in a closed-loop system with the Relaxograph and a syringe infusion pump was used to administer rocuronium at the rate necessary for a stable 90-99% block of the first twitch response (1% All neuromuscular transmission data, as well as the data on the infusion rate during the closed-loop system feed-back infusion of the relaxant, were saved in a Microsoft Excel compatible computer file.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• ASA physical status group I and II

• elective surgical procedures

• The subject has given written informed consent to participate

Exclusion Criteria:

• Coronary heart disease, bronchial asthma, cardiac, lung, hepatic and renal insufficiency

• Severe HBP, obesity (BMI>30)

• Neuromuscular and metabolic diseases

• Receiving medication known to influence neuromuscular transmission

• Pregnancy, psychiatric disease

• Allergy history

• Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sex
• TOF

Intervention

Drug:
• Propofol
This study was designed to determine the dose requirements for rocuronium, administered by continuous infusion to maintain a stable 90-99% T1 depression (depression of the first twitch in the train-of-four, TOF) in adult, elderly and different sex patients under sufentanil and propoful anaesthesia.
• Sevoflurane
This study was designed to determine the dose requirements for rocuronium, administered by continuous infusion to maintain a stable 90-99% T1 depression (depression of the first twitch in the train-of-four, TOF) in adult, elderly and different sex patients under sufentanil and sevoflurane anaesthesia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to give additional rocuromium	A personal computer, working in a closed-loop system with the Relaxograph and a syringe infusion pump was used to administer rocuronium at the rate necessary for a stable 90-99% block of the first twitch response (1%	24h	Yes
Secondary	Total dose of rocuronium	A personal computer, working in a closed-loop system with the Relaxograph and a syringe infusion pump was used to administer rocuronium at the rate necessary for a stable 90-99% block of the first twitch response (1%	24h	Yes
Secondary	Bispectral index(BIS)	The test is measured by bispectral index(BIS)form the patient arrive the operation room to leave the operation room.	24h	Yes
Secondary	Time to spontaneous breathing recovery, eye opening, extubation	Time to spontaneous breathing recovery, eye opening, extubation	24h	Yes
Secondary	Agitation score	The test is measured after extubation, 5min?10min and 15min after arrival at PACU	24h	Yes