Anesthesia, General Clinical Trial
Official title:
Evaluation of a Novel Closed-loop Propofol and Remifentanil System Guided by Bispectral Index Compared to a TCI Open-loop System: a Randomized Controlled Trial.
Closed loop system in intravenous anesthesia is more effective to maintain depth of
anesthesia compared with manual system open, it is unclear what driver and variables to
achieve this goal be more physiological; in the literature doesn´t exist studies showing
that the closed-loop system for both hypnotic and opioid is better than the controlled
pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain
anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in
closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for
propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was
integrated an additional closed system for remifentanil using hemodynamic variables and
control algorithm associated with bispectral index.
The purpose of this study is to determine the therapeutic effectiveness of a new system of
administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia
compared to an open loop system TCI.
Total intravenous anesthesia (TIVA) is a technique in which general anesthesia is
administered intravenously, exclusively, a combination of drugs in the absence of any
anesthetic agent inhaled1. TIVA development is closely linked to that of perfusion systems;
these make total intravenous anesthesia enjoy several advantages as high hemodynamic
stability, anesthetic depth more balanced, rapid and predictable recovery, less medication
administered, less pollution and lower toxicity , not only for the patient also for the
surgical equipment 2,3, 4 .
Two methods for controlling drug administration can be distinguished: open-loop and
closed-loop control.
Open loop control applies pharmacokinetics (PK)/pharmacodynamics (PD) models based on the
estimation of concentration of the drug in certain parts of the body, without measuring
these concentrations in real time. The inaccuracy resulting from the absolute concentration
requires the clinician to manually titrate dosage and objective observation based on the
concentration of the desired therapeutic effect. This titration requires high clinical
experience and a process of intensive monitoring, which may divert the attention from
critical situations which in turn leads to suboptimal therapy or even to put safety at risk
patient5, 6.
The application of closed-loop systems for the administration of an anesthetic requires a
perfect balance of all the basic components of a system of this type: a variable control of
the specific therapeutic effect; a target value for this variable (usually called set
point); an actuator control (in this case, the drug infusion pump); a system (in this case
the patient); and control algorithm7. This system excludes the control anesthesiologist drug
infusion which is determined by one or more clinical variables that directly reflect the
relationship PK / PD which previously established the attending anesthesiologist. The
controller automatically calculates the optimal rate of infusion based on the current value
and the desired value of the controlling variable and previously established mathematical
models.
With the appearance of electroencephalographic monitoring practice as a control variable,
began to conduct studies to assess the cerebral effect of anesthetics. Linear model two
compartments is used to describe the relationship of drug concentration and an adaptive
controller and this system was used subsequently using EEG to study the interaction of
opioid and propofol 8,9. After marketing bispectral index derived from the EEG, began to
evaluate closed loop systems using the BIS technology in several studies concluding that
such systems not only makes more predictable anesthetic depth, but provides greater
intraoperative hemodynamic stability and early recovery of the sedative and hypnotic effects
of propofol 10,11,12,13,14.
Closed loop system in intravenous anesthesia is more effective to maintain the depth of
anesthesia compared with manual system open, it is unclear what the driver and the variables
to achieve this goal be more physiological and accurately; in the literature doesn´t exist
studies showing that the closed-loop system for both hypnotic and opioid is better than the
controlled pharmacokinetic models and open loop system to maintain anesthetic depth. In
addition, the infusion of the opioid lacks physiological controllers in closed loop. Thus, a
system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based
on neuromonitoring bispectral index as anesthetic depth, and was integrated an additional
closed system for remifentanil using hemodynamic variables and control algorithm associated
with bispectral index.
The purpose of this study is to determine the therapeutic effectiveness of a new system of
administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia
compared to an open loop system TCI.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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