Phase 4 Completed N=80 Randomized Double-blind Treatment

Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients

Pre-eclampsia Aggravated

Source: ClinicalTrials.gov NCT01972659 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Feb 2014

Primary outcomePrimary: TOF 0.9 Achieving Time — 1.6; 2.1 minutes

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY TOF 0.9 Achieving Time	1.6; 2.1	—
SECONDARY Rocuronium Onset Time	—	—
SECONDARY Rocuronium Supplementation	—	—
SECONDARY Postoperative Morphine Consumption	—	—

Eligibility Criteria

Inclusion Criteria

female patients
American Society of Anesthesiologists (ASA) physical status I or II
18-60 years of age who were undergoing elective gynecological surgery
requiring endotracheal intubation were enrolled in this prospective study.

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
were pregnant
had a family history of malignant hyperthermia
detection if low or high control plasma magnesium levels

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01972659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.