Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex

Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01828385

Enrollment

Registered

2013-04-10

Start date

2012-10-31

Completion date

2013-02-28

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

Physiological Effects of Drugs, Rocuronium, Sugammadex sodium, Magnesium, Molecular Mechanisms of Pharmacological Action, Neuromuscular block, antagonism, Pharmacologic Actions

Brief summary

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.

Interventions

DRUGMagnesium Sulfate

Magnesium sulfate + rocuronium + sugammadex

DRUGSaline

Saline + rocuronium + sugammadex

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate	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.

Secondary

Measure	Time frame	Description
Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026