Neuromuscular BlockadePhase 4NCT01828385
Effect of Magnesium on the Recovery Time of Neuromuscular Blockade 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.
Trial summary
The aim of this study is to determine the recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Feb 2013
- 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
- Age 18-65 years
- ASA physical status 1 or 2
- weight BMI 18.5-24.9
- otorhinolaryngological surgeries
Who cannot join
- major surgery associated with massive blood loss or fluid replacement
- any known allergy to magnesium sulphate or any other study drugs
- pregnant
- anatomical malformations expected to result in a difficult intubation;
- known or suspected neuromuscular disorders and/or significant hepatic or renal dysfunction
- administration of any medication known to interfere with neuromuscular blocking agents (such as anticonvulsants, aminoglycosides, calcium channel blockers and magnesium containing medications)
- hypomagnesemia, hypermagnesemia, hypocalcemia, hypercalcemia
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, 21041-030
About this study
Official title: Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial
The aim of this study is to determine the recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate.
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: evaluate the effect of pretreatment with magnesium sulfate on the time reversal with sugammadex (recovery of the T4/T1 ratio = 0.9) of moderate neuromuscular blockade (two answers to a train-of-four TOF) induced by rocuronium.
Secondary outcome: evaluate severe respiratory events, the incidence of residual neuromuscular blockade in the post anesthesia recovery room and postoperative pain.
- Conditions
- Neuromuscular Blockade
- Being tested
- Magnesium Sulfate, Saline
- Keywords
- Physiological Effects of Drugs, Rocuronium, Sugammadex sodium, Magnesium, Molecular Mechanisms of Pharmacological Action, Neuromuscular block, antagonism, Pharmacologic Actions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Magnesium sulfate + rocuronium + sugammadex
SalineDrug
Saline + rocuronium + sugammadex
| Study group | Role | What they receive |
|---|---|---|
| Group Mg | Experimental | Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1 Receives: Drug: Magnesium Sulfate |
| Group C | Active comparator | Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1 Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate
When T1 reached 25%, a single bolus dose of sugammadex 2 mg.kg-1 was administered to facilitate the recovery. The times to reach a TOF ratio of 0.9 and T1 height value were measured.
Measured: 3 hours
Secondary outcomes (1)
Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia 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: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Federal de Bonsucesso
- Responsible party
- Principal investigator, Paulo Alipio Germano Filho, Universidade Federal do Rio de Janeiro
- Investigators
- Paulo A Germano Filho, MD, Principal investigator, Hospital Federal de BonsucessoNúbia V Figueiredo, PhD, Study director, Universidade Federal do Rio de JaneiroIsmar L Cavalcanti, PhD, Study director, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828385
- Sponsor's protocol ID
- PAGF-01M
- Status last verified
- Jan 2015
- First submitted
- 5 Apr 2013
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.
PubMed 21364460Sauer M, Stahn A, Soltesz S, Noeldge-Schomburg G, Mencke T. The influence of residual neuromuscular block on the incidence of critical respiratory events. A randomised, prospective, placebo-controlled trial. Eur J Anaesthesiol. 2011 Dec;28(12):842-8. doi: 10.1097/EJA.0b013e328345cd11.
PubMed 21455074
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT01828385
- Acronym / sponsor ID
- PAGF-01M
- Conditions
- Neuromuscular Blockade
- Keywords
- Physiological Effects of Drugs, Rocuronium, Sugammadex sodium, Magnesium, Molecular Mechanisms of Pharmacological Action, Neuromuscular block, antagonism, Pharmacologic Actions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Hospital Federal de Bonsucesso
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Apr 2013 (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 determine the recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate.
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: evaluate the effect of pretreatment with magnesium sulfate on the time reversal with sugammadex (recovery of the T4/T1 ratio = 0.9) of moderate neuromuscular blockade (two answers to a train-of-four TOF) induced by rocuronium.
Secondary outcome: evaluate severe respiratory events, the incidence of residual neuromuscular blockade in the post anesthesia recovery room and postoperative pain.
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 |
|---|---|---|
| Group Mg | Experimental | Drug: Magnesium SulfateMagnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1 |
| Group C | Active comparator | Drug: SalineSaline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- ASA physical status 1 or 2
- weight BMI 18.5-24.9
- otorhinolaryngological surgeries
Key exclusion criteria (7 listed)
- major surgery associated with massive blood loss or fluid replacement
- any known allergy to magnesium sulphate or any other study drugs
- pregnant
- anatomical malformations expected to result in a difficult intubation;
- known or suspected neuromuscular disorders and/or significant hepatic or renal dysfunction
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 SulfateMagnesium sulfate + rocuronium + sugammadex | Drug | Group Mg |
| SalineSaline + rocuronium + sugammadex | Drug | Group C |
Primary outcome
Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate
Time frame: 3 hours
When T1 reached 25%, a single bolus dose of sugammadex 2 mg.kg-1 was administered to facilitate the recovery. The times to reach a TOF ratio of 0.9 and T1 height value were measured.
1 secondary outcome
Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room
Time frame: 4 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 21 Jan 2015.
- Background: PubMed 21364460Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.
- Background: PubMed 21455074Sauer M, Stahn A, Soltesz S, Noeldge-Schomburg G, Mencke T. The influence of residual neuromuscular block on the incidence of critical respiratory events. A randomised, prospective, placebo-controlled trial. Eur J Anaesthesiol. 2011 Dec;28(12):842-8. doi: 10.1097/EJA.0b013e328345cd11.
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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, MD principal investigator
Hospital Federal de Bonsucesso
Núbia V Figueiredo, PhD study director
Universidade Federal do Rio de Janeiro
Ismar L Cavalcanti, 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 4 inclusion and 7 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 21 Jan 2015. 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. 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?
Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate (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 NCT01828385, which also lists 2 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 21 Jan 2015.