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Evaluation of onset time and duration of Rocuronium in differet doses when used with Magnesium Sulfate

Interference of Magnesium Sulfate in onset time and duration of Rocuronium in different doses

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-96cy3k
Enrollment
Unknown
Registered
2016-09-09
Start date
2014-01-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Aspiration pneumonia, neuromuscular nondepolarizing agents, intratracheal intubation

Interventions

After the randomization, 180 patients will be divided into 2 groups: a) Intervention (90 patients): receive, intravenously, Magnesium Sulfate (60 mg/kg plus 0.9% saline solution in 100 ml final volum
Drug

Sponsors

Hospital Universitário Cassiano Antônio de Moraes
Lead Sponsor
Hospital Universitário Cassiano Antônio de Moraes
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients of aged 18 to 65 years; both gender; ASA physical status I or II; body mass index (BMI) between 18 and 27; with general anesthesia indication under tracheal intubation and controlled mechanical ventilation for elective surgical procedures indicating use of muscle relaxant.

Exclusion criteria

Exclusion criteria: Use drugs that can influence neuromuscular blockade (as phenytoin and aminoglycosides); hepatic, renal ou cardiac impairment; neuromuscular disease; predictability of difficulty in ventilation by mask or intubation; risk or confirmation of pregnancy; patients with inadequate preoperative fasting or at risk of pulmonary aspiration; electrolyte disorders, use magnesium supplementation; other contraindications to the use of parenteral magnesium; surgery associated with massive bleeding or high volume replacements; patients that develop electrolyte or acid-base disturbance, hypothermia or any other intraoperative condition that interferes with neuromuscular blockade

Design outcomes

Primary

MeasureTime frame
Variation in onset time (time until 5% of the initial motor response), clinical duration (time to 25% recovery of neuromuscular function) and 25-75% recovery time (time for recovery of 25 to 75% neuromuscular function) of neuromuscular blockade induced by rocuronium in different doses associated or not with Magnesium Sulfate, measured by accelerometry the first finger after single twitch (1 Hz) of the ulnar nerve, considered significant a difference of 10% between groups (with or without Magnesium Sulfate), corresponding to approximately 10 seconds.

Secondary

MeasureTime frame
Improvement in tracheal intubation conditions by clinical analysis of the reaction to the endotracheal tube introduction (none, mild and strong), the position of the vocal cords (abduction, intermediate or closed) and the quality of laryngoscopy (excellent, good or bad) evidenced by increasing conditions "clinically acceptable" according to "Good clinical research practice in pharmacodynamics studies of neuromuscular blocking agents II: the Stockholm revision". Reduced adrenergic response to tracheal intubation by heart rate and noninvasive blood pressure, detected from a variation of less than 5% in measurements before and after tracheal intubation. Increased blood flow in the place of the neuromuscular junction monitoring(adductor muscle of the first finger) after infusion of Magnesium Sulfate/Placebo, inferred by the skin temperature of thenar eminence and perfusion index (plethysmography pulse oximeter installed on the first chirodactyl) detected by increase greater than 10% for the perfusion index and 0.5 degrees celsius for temperature.

Countries

Brazil

Contacts

Public ContactCarlos David de Almeida

Hospital Universitário Cassiano Antônio de Moraes

cedalmeida@gmail.com+55(27)999821227

Outcome results

None listed

Source: REBEC (via WHO ICTRP)