Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989272
• Other study ID #: HFBonsucesso
• Status: Recruiting
• Phase: Phase 4
• First received: December 5, 2016
• Last updated: December 9, 2016
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Hospital Federal de Bonsucesso
• Contact: Angelo Jorge Q R Micuci, doctor anesthesiology
• Phone: 21997828668
• Email: angelojorgemicuci[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Neuromuscular Blockade
• Magnesium Sulfate
• Neuromuscular Blockade
• Rocuronium

Intervention

Drug:
• Sulfate, Magnesium
magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg

Other:
• saline group
saline group (30 patients) who will receive pretreatment by saline solution

Locations

Country	Name	City	State
Brazil	Bonsucesso Federal Hospital	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Federal de Bonsucesso

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of deep neuromuscular block	To determine the duration of deep neuromuscular block following a single dose of rocuronium	perioperative	Yes
Secondary	onset time and recovery time of rocuronium	to determine the pharmacodynamic parameters of rocuronium	perioperative- until 48h	Yes
Secondary	residual neuromuscular block in PACU	Evaluate the eventual occurrence of residual neuromuscular block in PACU	6h	Yes
Secondary	evolution of the height of T1	Record the evolution of the height of T1	perioperative- until 48h	Yes
Secondary	postoperative pain	Evaluate postoperative pain with questionnaire and visual scale of pain	perioperative- until 48h	Yes
Secondary	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	Yes
Secondary	frequency of pain or unpleasant sensation	Evaluate frequency of pain or unpleasant sensation during the infusion of the studied solutions	perioperative- until 48h	Yes