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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saline group | Placebo Comparator | Control group (30 patients), who will receive Treatment by venous infusion of saline solution |
|
| Sulfate group | Experimental | magnesium group (30 patients) who will receive pre- Venous infusion of magnesium sulphate 60 mg / kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfate, Magnesium | Drug | magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| duration of deep neuromuscular block | To determine the duration of deep neuromuscular block following a single dose of rocuronium | perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| onset time and recovery time of rocuronium | to determine the pharmacodynamic parameters of rocuronium | perioperative- until 48h |
| residual neuromuscular block in PACU | Evaluate the eventual occurrence of residual neuromuscular block in PACU |
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Inclusion Criteria:
Exclusion Criteria:
Refusal to participate in the study;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelo Jorge Q R Micuci, doctor anesthesiology | Contact | 21997828668 | 55 | angelojorgemicuci@gmail.com |
| Ismar L Cavalcanti, master | Contact | 999822993 | 55 | ismarcavalcanti@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nubia V Figueiredo, master | Universidade Federal do Rio de Janeiro | Study Director |
| Ismar L Cavalcanti, master | Federal Fluminense University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bonsucesso Federal Hospital | Recruiting | Rio de Janeiro | Rio de Janeiro | 21.041-030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30985540 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 9, 2018 | |
| Unrelease | Nov 29, 2018 | |
| Release | Nov 29, 2018 |
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| saline group | Other | saline group (30 patients) who will receive pretreatment by saline solution |
|
| 6h |
| evolution of the height of T1 | Record the evolution of the height of T1 | perioperative- until 48h |
| postoperative pain | Evaluate postoperative pain with questionnaire and visual scale of pain | 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 | perioperative- until 48h |
| frequency of pain or unpleasant sensation | Evaluate frequency of pain or unpleasant sensation during the infusion of the studied solutions | perioperative- until 48h |
| Angelo Jorge Q R Micuci, doctor anesthesiology |
| Hospital federal of Bonsucesso |
| Principal Investigator |
| Reset | Mar 14, 2019 |
| Release | Mar 16, 2019 |
| Reset | Jun 13, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 9, 2018 | Nov 29, 2018 | |||
| Nov 29, 2018 | Mar 14, 2019 | |||
| Mar 16, 2019 | Jun 13, 2019 |
| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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