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

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

Study Overview

• Status: Unknown
• Conditions: Neuromuscular Blockade; Magnesium Sulfate; Rocuronium; Deep Neuromuscular Blockade
• Intervention / Treatment: Other: saline group; Drug: Sulfate, Magnesium

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Angelo Jorge Q R Micuci, doctor anesthesiology; Phone Number: 55 21997828668; Email: angelojorgemicuci@gmail.com
• Study Contact Backup: Name: Ismar L Cavalcanti, master; Phone Number: 55 999822993; Email: ismarcavalcanti@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21.041-030
    • Recruiting
    • Bonsucesso Federal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: saline group; Control group (30 patients), who will receive Treatment by venous infusion of saline solution	Other: saline group; saline group (30 patients) who will receive pretreatment by saline solution
Experimental: Sulfate 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of deep neuromuscular block	To determine the duration of deep neuromuscular block following a single dose of rocuronium	perioperative

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospital Federal de Bonsucesso
• Investigators: Study Director: Nubia V Figueiredo, master, Universidade Federal do Rio de Janeiro; Study Director: Ismar L Cavalcanti, master, Federal Fluminense University; Principal Investigator: Angelo Jorge Q R Micuci, doctor anesthesiology, Hospital federal of Bonsucesso

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Estimate): December 12, 2016
• Last Update Submitted That Met QC Criteria: December 9, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: HFBonsucesso

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES