Neuromuscular BlockadePhase 4NCT02932254

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

A Phase 4 study testing Magnesium Sulfate and Saline in people with Neuromuscular Blockade, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Neuromuscular Blockade
What is being tested?: Magnesium Sulfate and Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteBrazil
Study dates: Oct 2016to Mar 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ASA physical status 1 or 2
weight BMI 18.5-24.9
otorhinolaryngological surgeries

Who cannot join

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);

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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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital Federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, 22271042

Other trials in Brazil

About this study

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.

Read the detailed description

Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma, antinociceptive action and neuroprotective effects. However, its use is limited because magnesium potentiates non-depolarizing neuromuscular blocking agents.

Primary outcome: evaluating the effect of treatment with magnesium sulfate the T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium.

Secondary outcome: evaluate the occurrence of severe respiratory events, the incidence of residual neuromuscular block in the post-anesthetic recovery room, evolution of T1 high, and postoperative pain.

Conditions: Neuromuscular Blockade
Being tested: Magnesium Sulfate, Saline
Keywords: Physiological Effects of Drugs, Rocuronium, Sugammadex sodium, Magnesium, Neuromuscular block, antagonism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnesium SulfateDrug
Also called magnesium sulphate
After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).
SalineDrug
Also called NaCl 0,9%
After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).

Study groups in NCT02932254
Study group	Role	What they receive
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). Receives: 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. Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 hours

Secondary outcomes (5)

Record the possible serious respiratory events in the post-anesthetic recovery room
Obstruction of the upper airway that requires intervention; mild to moderate hypoxemia - lower saturation between 90% -93%, with no improvement after request to deep breathing or tactile stimulation; severe hypoxemia - saturation less than 90%, with no improvement after request to deep breathing or tactile stimulation; signs of increased work of breathing - more than 20 breaths per minute and use of accessory muscles; inability to breathe deeply when requested; via musculature of signs of weakness air higher, as speech disability; reintubation in the post anesthetic recovery room; clinical evidence or suspicion of bronchial aspiration after extubation (gastric contents oropharyngeal or tracheal tube accompanied by hypoxemia).
Measured: 1 hour after the end of surgery
Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room
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.
Measured: 1 hour after the end of surgery
Record the evolution of the height of the first response (T1)
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.
Measured: 1 hour after the end of surgery
Record the possible occurrence of severe respiratory complications every 24 hours
Obstruction of the upper airway that requires intervention; mild to moderate hypoxemia - lower saturation between 90% -93%, with no improvement after request to deep breathing or tactile stimulation; severe hypoxemia - saturation less than 90%, with no improvement after request to deep breathing or tactile stimulation; signs of increased work of breathing - more than 20 breaths per minute and use of accessory muscles; inability to breathe deeply when requested; via musculature of signs of weakness air higher, as speech disability; reintubation in the post anesthetic recovery room; clinical evidence or suspicion of bronchial aspiration after extubation (gastric contents oropharyngeal or tracheal tube accompanied by hypoxemia).
Measured: 72 hours max
Evaluate postoperative pain
Use of visual analogue pain scale (0-10) questionnaire
Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Mar 2017

First posted13 Oct 2016 (estimated)
Study startOct 2016
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02932254
Sponsor's protocol ID: PAGF02MG
Status last verified: Feb 2018
First submitted: 25 Jul 2016
Last updated: 12 Feb 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25582520
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.
PubMed 22183158
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.
PubMed 25962433

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex
ClinicalTrials.gov ID: NCT02932254
Acronym / sponsor ID: PAGF02MG
Conditions: Neuromuscular Blockade
Keywords: Physiological Effects of Drugs, Rocuronium, Sugammadex sodium, Magnesium, Neuromuscular block, antagonism
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Universidade Federal do Rio de JaneiroUniversity, hospital or other
Study start: Oct 2016 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 13 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Primary outcome: evaluating the effect of treatment with magnesium sulfate the T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Magnesium Sulfate	Active comparator	Drug: Magnesium Sulfate1. 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).
Saline Solution	Placebo comparator	Drug: Saline1. 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

ASA physical status 1 or 2
weight BMI 18.5-24.9
otorhinolaryngological surgeries

Key exclusion criteria (10 listed)

refusal to participate in the study;
pregnancy or suspected pregnancy;
neuromuscular diseases, renal or hepatic impairment;
hepatic dysfunction;
story or predictors of difficult airway;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Magnesium SulfateAlso: magnesium sulphateAfter 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).	Drug	Magnesium Sulfate
SalineAlso: NaCl 0,9%After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).	Drug	Saline Solution

Primary outcome

Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio .
Time frame: 3 hours
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.

5 secondary outcomes

Record the possible serious respiratory events in the post-anesthetic recovery room
Time frame: 1 hour after the end of surgery
Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room
Time frame: 1 hour after the end of surgery
Record the evolution of the height of the first response (T1)
Time frame: 1 hour after the end of surgery
Record the possible occurrence of severe respiratory complications every 24 hours
Time frame: 72 hours max
Evaluate postoperative pain
Time frame: 72 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
Background: PubMed 25582520Unterbuchner 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.
Results publication: PubMed 22183158Hans 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.
Results publication: PubMed 25962433Carron 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.
Individual participant dataSharing planned: No

Related trials for Neuromuscular Blockade

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paulo A Germano Filho, MSc principal investigator

Hospital Federal de Bonsucesso

Ismar L Cavalcanti, PhD study director

Universidade Federal Fluminense

Nubia V Figueiredo, PhD study director

Universidade Federal do Rio de Janeiro

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Magnesium Sulfate and Saline in people with Neuromuscular Blockade, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio . (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932254, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.