A Phase 4 interventional study of Sulfate, Magnesium and saline group in Magnesium Sulfate, Neuromuscular Blockade and Rocuronium, sponsored by Hospital Federal de Bonsucesso. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-12.
Sponsored by Hospital Federal de Bonsucesso · Phase 4, Interventional, and Treatment
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.
Hospital Federal de Bonsucesso is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Refusal to participate in the study;
Control group (30 patients), who will receive Treatment by venous infusion of saline solution
Other: saline group
magnesium group (30 patients) who will receive pre- Venous infusion of magnesium sulphate 60 mg / kg
Drug: Sulfate, Magnesium
magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg
saline group (30 patients) who will receive pretreatment by saline solution
duration of deep neuromuscular block
To determine the duration of deep neuromuscular block following a single dose of rocuronium
Time frame: perioperative
onset time and recovery time of rocuronium
to determine the pharmacodynamic parameters of rocuronium
Time frame: perioperative- until 48h
residual neuromuscular block in PACU
Evaluate the eventual occurrence of residual neuromuscular block in PACU
Time frame: 6h
evolution of the height of T1
Record the evolution of the height of T1
Time frame: perioperative- until 48h
postoperative pain
Evaluate postoperative pain with questionnaire and visual scale of pain
Time frame: perioperative- until 48h
episodes of nausea and vomiting and treatment of surgery to discharge
Assess the frequency of individual episodes of nausea and vomiting and treatment during the period from the end of surgery to discharge
Time frame: perioperative- until 48h
frequency of pain or unpleasant sensation
Evaluate frequency of pain or unpleasant sensation during the infusion of the studied solutions
Time frame: perioperative- until 48h
Plan to share: Yes
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Hospital Federal de Bonsucesso