Sex Clinical Trial
Official title:
Effect of Different Anesthetics on Pharmacokinetics and Pharmacodynamics of Rocuronium in Closed－Loop Muscle Relaxant Infusion System
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.
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%<T1<10%). The infusion
of rocuronium was started automatically when T1 returned to 5% of the control value. The
initial infusion rate was set at 10 mg/kg/min, and subsequently adjusted by the computer.
Every 10 s the computer received data (T1 value) from the Relaxograph. If T1 increased above
10%, the infusion rate was increased by 2/3. If T1 increased above 15%, a bolus dose (0.06
mg/kg) was administered automatically to avoid an undesirable return of the muscle strength
during surgery. The neuromuscular block was considered stable if T1 changed by no more than
2% over a 10-min observation period. The rocuronium infusion was automatically stopped if
three consecutive T1 values equalled 0. The working mode (automatic or manual), the last six
T1 values and the 15-min T1 trend could be observed on screen. The anaesthesiologist could
override the computer-set infusion rate at any time, by changing the working mode from
automatic to manual, and stop the infusion when the surgery was completed.
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.
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