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

NCT02989272 | Unknown Phase 4 DMC

• 1 other identifier: HFBonsucesso
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Magnesium Sulfate; Neuromuscular Blockade; Rocuronium; Deep Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• duration of deep neuromuscular block

  To determine the duration of deep neuromuscular block following a single dose of rocuronium

  perioperative

Secondary Outcomes (6)

• onset time and recovery time of rocuronium

  perioperative- until 48h

• residual neuromuscular block in PACU

  6h

• evolution of the height of T1

  perioperative- until 48h

• postoperative pain

  perioperative- until 48h

• episodes of nausea and vomiting and treatment of surgery to discharge

  perioperative- until 48h

Study Arms (2)

saline group

PLACEBO COMPARATOR

Control group (30 patients), who will receive Treatment by venous infusion of saline solution

Other: saline group

Sulfate group

EXPERIMENTAL

magnesium group (30 patients) who will receive pre- Venous infusion of magnesium sulphate 60 mg / kg

Drug: Sulfate, Magnesium

Interventions

Sulfate, Magnesium DRUG

magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg

Sulfate group

saline group OTHER

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

saline group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Federal de Bonsucesso: lead

Study Sites (1)

Bonsucesso Federal Hospital

Rio de Janeiro, Rio de Janeiro, 21.041-030, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 30985540 DERIVED

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Nubia V Figueiredo, master

  Universidade Federal do Rio de Janeiro

  STUDY DIRECTOR

• Ismar L Cavalcanti, master

  Federal Fluminense University

  STUDY DIRECTOR

• Angelo Jorge Q R Micuci, doctor anesthesiology

  Hospital federal of Bonsucesso

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelo Jorge Q R Micuci, doctor anesthesiology

CONTACT

21997828668; angelojorgemicuci@gmail.com

Ismar L Cavalcanti, master

CONTACT

999822993; ismarcavalcanti@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Anesthesiologist

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 12, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 12, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)