Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex
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| ClinicalTrials.gov Identifier: NCT01828385 |
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Recruitment Status :
Completed
First Posted : April 10, 2013
Last Update Posted : January 21, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuromuscular Blockade | Drug: Magnesium Sulfate Drug: Saline | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | February 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group Mg
Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1
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Drug: Magnesium Sulfate
Magnesium sulfate + rocuronium + sugammadex |
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Active Comparator: Group C
Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1
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Drug: Saline
Saline + rocuronium + sugammadex |
- 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.
- Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room [ Time Frame: 4 hours ]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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-65 years
- ASA physical status 1 or 2
- weight BMI 18.5-24.9
- otorhinolaryngological surgeries
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828385
| Brazil | |
| Hospital Federal de Bonsucesso | |
| Rio de Janeiro, RJ, Brazil, 21041-030 | |
| Principal Investigator: | Paulo A Germano Filho, MD | Hospital Federal de Bonsucesso | |
| Study Director: | Núbia V Figueiredo, PhD | Universidade Federal do Rio de Janeiro | |
| Study Director: | Ismar L Cavalcanti, PhD | Universidade Federal do Rio de Janeiro |
| Responsible Party: | Paulo Alipio Germano Filho, MD, MSc, Universidade Federal do Rio de Janeiro |
| ClinicalTrials.gov Identifier: | NCT01828385 |
| Other Study ID Numbers: |
PAGF-01M |
| First Posted: | April 10, 2013 Key Record Dates |
| Last Update Posted: | January 21, 2015 |
| Last Verified: | January 2015 |
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Physiological Effects of Drugs Rocuronium Sugammadex sodium Magnesium |
Molecular Mechanisms of Pharmacological Action Neuromuscular block, antagonism Pharmacologic Actions |
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Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents |
Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents |