Clinical trial NCT02989272: Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium
Official title: Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium: Random and Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Magnesium Sulfate
Neuromuscular Blockade
Rocuronium
Deep Neuromuscular Blockade
Lead sponsor: Hospital Federal de Bonsucesso
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Physical State American Society of Anesthesiologists (ASA) I, II and III; Body mass index between 18.5 and 24.9;Otorhinolaryngological surgeries

Exclusion Criteria:

Refusal to participate in the study;

* Pregnancy or suspected pregnancy; Neuromuscular diseases, renal or hepatic impairment;
* Hepatic dysfunction;
* History or predictors of difficult airway; Hypermagnesemia (Mg\> 2.5 mEq / L);
* Hypomagnesemia (Mg \<1.7 mEq / L);
* Use of furosemide, aminoglycosides, aminophylline, azathioprine; Cyclophosphamide, anti-inflammatories and magnesium;
* Allergy to the drugs used in the study;
* Participants from other clinical studies.
* Emergency surgeries.

Primary outcomes:
measure: duration of deep neuromuscular block
timeFrame: perioperative
Secondary outcomes:
measure: onset time and recovery time of rocuronium
timeFrame: perioperative- until 48h
measure: residual neuromuscular block in PACU
timeFrame: 6h
measure: evolution of the height of T1
timeFrame: perioperative- until 48h
measure: postoperative pain
timeFrame: perioperative- until 48h
measure: episodes of nausea and vomiting and treatment of surgery to discharge
timeFrame: perioperative- until 48h
measure: frequency of pain or unpleasant sensation
timeFrame: perioperative- until 48h
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Bonsucesso Federal Hospital
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Nubia V Figueiredo, master
role: STUDY_DIRECTOR
affiliation: Federal Fluminense University
name: Ismar L Cavalcanti, master
role: STUDY_DIRECTOR
affiliation: Hospital federal of Bonsucesso
name: Angelo Jorge Q R Micuci, doctor anesthesiology
role: PRINCIPAL_INVESTIGATOR
References:
citation: Queiroz Rangel Micuci AJ, Vercosa N, Filho PAG, de Boer HD, Barbosa DD, Cavalcanti IL. Effect of pretreatment with magnesium sulphate on the duration of intense and deep neuromuscular blockade with rocuronium: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):502-508. doi: 10.1097/EJA.0000000000001003.