Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex

NCT02932254 | Completed Phase 4

• 1 other identifier: PAGF02MG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 / T1 ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by rocuronium.

Conditions

Neuromuscular Blockade

Keywords

Physiological Effects of Drugs; Rocuronium; Sugammadex sodium; Magnesium; Neuromuscular block, antagonism

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio .

  The T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium.Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX.

  3 hours

Secondary Outcomes (5)

• Record the possible serious respiratory events in the post-anesthetic recovery room

  1 hour after the end of surgery

• Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room

  1 hour after the end of surgery

• Record the evolution of the height of the first response (T1)

  1 hour after the end of surgery

• Record the possible occurrence of severe respiratory complications every 24 hours

  72 hours max

• Evaluate postoperative pain

  72 hours

Study Arms (2)

Magnesium Sulfate

ACTIVE COMPARATOR

1. After anaesthesia induction and calibration of neuromuscular monitoring (acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. 2. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) or reappearance of 2 twitches of the train of four (moderate neuromuscular block), 4 mg/kg (deep neuromuscular block) or 2 mg/kg (moderate neuromuscular block) of sugammadex are given intravenously. 3. INTERVENTION: After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).

Drug: Magnesium Sulfate

Saline Solution

PLACEBO COMPARATOR

1. After anaesthesia induction and calibration of neuromuscular monitoring (acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. 2. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) or reappearance of 2 twitches of the train of four (moderate neuromuscular block), 4 mg/kg (deep neuromuscular block) or 2 mg/kg (moderate neuromuscular block) of sugammadex are given intravenously. 3. INTERVENTION: After 90% of baseline T4 / T1, are injected intravenously 100 mL saline solution over 10 minutes.

Drug: Saline

Interventions

Magnesium Sulfate DRUG

After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).

Also known as: magnesium sulphate

Magnesium Sulfate

Saline DRUG

After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).

Also known as: NaCl 0,9%

Saline Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status 1 or 2
• weight BMI 18.5-24.9
• 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;
• story or predictors of difficult airway;
• hypermagnesemia (Mg\> 2.5 mEq / L);
• hypomagnesemia (Mg \<1.7 mEq / L);
• furosemide, aminoglycosides, aminophylline azathioprine; cyclophosphamide, anti-inflammatory and magnesium;
• allergy to drugs used in the study;
• participants from other clinical studies.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Hospital Federal de Bonsucesso

Rio de Janeiro, Rio de Janeiro, 22271042, Brazil

Location

Related Publications (3)

• Unterbuchner C, Ziegleder R, Graf B, Metterlein T. Magnesium-induced recurarisation after reversal of rocuronium-induced neuromuscular block with sugammadex. Acta Anaesthesiol Scand. 2015 Apr;59(4):536-40. doi: 10.1111/aas.12461. Epub 2015 Jan 13.

  PMID: 25582520 BACKGROUND

• Hans GA, Bosenge B, Bonhomme VL, Brichant JF, Venneman IM, Hans PC. Intravenous magnesium re-establishes neuromuscular block after spontaneous recovery from an intubating dose of rocuronium: a randomised controlled trial. Eur J Anaesthesiol. 2012 Feb;29(2):95-9. doi: 10.1097/EJA.0b013e32834e13a6.

  PMID: 22183158 RESULT

• Carron M, Ori C. Magnesium-induced recurarisation after reversal of rocuronium-induced neuromuscular block with sugammadex. Findings vs. speculation. Acta Anaesthesiol Scand. 2015 Aug;59(7):946-7. doi: 10.1111/aas.12551. Epub 2015 May 12. No abstract available.

  PMID: 25962433 RESULT

MeSH Terms

Interventions

Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Paulo A Germano Filho, MSc

  Hospital Federal de Bonsucesso

  PRINCIPAL INVESTIGATOR

• Ismar L Cavalcanti, PhD

  Universidade Federal Fluminense

  STUDY DIRECTOR

• Nubia V Figueiredo, PhD

  Universidade Federal do Rio de Janeiro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: October 13, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)