Neuromuscular Blockade Clinical Trial
Official title:
Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium: Random and Double-blind Clinical Study
It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis
is that pre-treatment with magnesium sulfate, due to its action at the neuromuscular
junction,potentiate the duration of deep neuromuscular block following rocuronium
curarization in patients undergoing general anesthesia. Magnesium sulphate has gained
prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of
neuromuscular blockade among other functions.
The deep neuromuscular block is defined as the one obtained by the absence of response to
the sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic
counts . There is no literature description of the role of magnesium sulphate in Duration of
the deep neuromuscular block obtained after the muscle relaxation of patients with
rocuronium This study is justified because extending the clinical duration of neuromuscular
blockers may translate into gains for surgeries that require deep and long-lasting muscle
relaxation as in laparoscopic and robotic surgeries. This block allows lower inflation
pressures of the pneumoperitoneum to be obtained, as a result, there is a lower inflammatory
and cardiorespiratory repercussion for the patient
Patients will be selected from those who use the General Surgery Service of the Federal
Hospital of Bonsucesso for medical indication or own will, obeying the inclusion and
exclusion criteria. After signing the informed consent, they will be evaluated clinically
and laboratorially, according to the routine of preoperative exams and pre-anesthetic
outpatient evaluation. Patients will be allocated to one of two groups: control group (30
patients), who will receive pretreatment by venous infusion of saline solution; And
magnesium group (30 patients) who will receive pretreatment by intravenous infusion of
magnesium sulfate 60 mg / kg according to the random number sequence generated
electronically through the QuickCalcs program (GraphPad Software, San Diego, CA) Because it
is a double-blind study, both the researcher and the patient will not know which of the
groups will be studied.
The principal investigator will be responsible for the delivery of sealed envelope
containing the sequence of cases allocated in each of the groups to another anesthesiologist
who will prepare the solution (saline or magnesium sulphate) and will record in a specific
file in which group the volunteer was Allocated. Again the envelope will be sealed for
tabulation later, without the knowledge of the researcher. The same principal investigator
will be in charge of the measurement and recording of the data collected.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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