- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932254
Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 22271042
- Hospital Federal de Bonsucesso
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA physical status 1 or 2
- weight BMI 18.5-24.9
- otorhinolaryngological surgeries
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Magnesium Sulfate
|
After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).
Other Names:
|
Placebo Comparator: Saline Solution
|
After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Record the possible serious respiratory events in the post-anesthetic recovery room
Time Frame: 1 hour after the end of surgery
|
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).
|
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
|
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.
|
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
|
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.
|
1 hour after the end of surgery
|
Record the possible occurrence of severe respiratory complications every 24 hours
Time Frame: 72 hours max
|
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).
|
72 hours max
|
Evaluate postoperative pain
Time Frame: 72 hours
|
Use of visual analogue pain scale (0-10) questionnaire
|
72 hours
|
Collaborators and Investigators
Investigators
- Study Director: Nubia V Figueiredo, PhD, Universidade Federal do Rio de Janeiro
- Principal Investigator: Paulo A Germano Filho, MSc, Hospital Federal de Bonsucesso
- Study Director: Ismar L Cavalcanti, PhD, Universidade Federal Fluminense
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- PAGF02MG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuromuscular Blockade
-
Hospital Federal de BonsucessoUnknownNeuromuscular Blockade | Magnesium Sulfate | Rocuronium | Deep Neuromuscular BlockadeBrazil
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...CompletedNeuromuscular Blockade | Neuromuscular MonitoringItaly
-
Universitair Ziekenhuis BrusselUnknownNeuromuscular Blockade | Neuromuscular MonitoringBelgium
-
Central Hospital, Nancy, FranceNot yet recruitingComparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function (DECURAR-EMG)Neuromuscular BlockadeFrance
-
Vanderbilt University Medical CenterUniversity of Pittsburgh; The Cooper Health SystemRecruitingNeuromuscular BlockadeUnited States
-
Leiden University Medical CenterMerck Sharp & Dohme LLCCompletedNeuromuscular BlockadeNetherlands
-
Seoul National University Bundang HospitalCompleted
-
Poitiers University HospitalEnrolling by invitationNeuromuscular BlockadeFrance
-
Centre Hospitalier Universitaire Dinant Godinne...CompletedNeuromuscular BlockadeBelgium
-
Seoul National University HospitalCompletedNeuromuscular BlockadeKorea, Republic of
Clinical Trials on Magnesium Sulfate
-
University of OklahomaRecruitingAsthma in Children | Asthma AttackUnited States
-
Sohag UniversityRecruitingPost Operative Pain, AcuteEgypt
-
Thomas Jefferson UniversityNot yet recruiting
-
Sohag UniversityCompletedPersistent Pulmonary Hypertension of the Newborn | PPHN | Persistent Fetal CirculationEgypt
-
Instituto Materno Infantil Prof. Fernando FigueiraCompletedSevere PreeclampsiaBrazil
-
Queen Sirikit National Institute of Child HealthUnknownAcute Severe AsthmaThailand
-
Assiut UniversityCompletedMaternal Care PatternsEgypt
-
Assiut UniversityRecruitingIntracranial Pressure Control in Pre-eclampsiaEgypt
-
University of Texas Southwestern Medical CenterCompletedAsthmaUnited States
-
University of MonastirCompletedAtrial FibrillationTunisia