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Clinical Trial Summary

Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.

Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.


Clinical Trial Description

Inclusion criteria:

- American Society of Anesthesiologists physical status I or II

- 18-60 years of age

- undergoing elective gynecological surgery

- requiring endotracheal intubation

Exclusion criteria:

- Patients who had body mass index > 35

- gastroesophageal reflux

- a history of allergy

- used medication known to interact with the drugs being used in this trial

- who experienced expected or unexpected difficulty during intubation or ventilation

- had neuromuscular disease

- hepatic or renal insufficiency

- pregnant

- were American Society of Anesthesiologists III or IV

- had a family history of malignant hyperthermia

- detection if low or high control plasma magnesium levels ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01972659
Study type Interventional
Source Kocaeli University
Contact
Status Completed
Phase Phase 4
Start date October 2012
Completion date December 2013

See also
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