Phase 4
N=80
Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Pre-eclampsia Aggravated
Bottom Line
View on ClinicalTrials.gov: NCT01972659 ↗Enrolled (actual)
80
Serious AEs
—
Results posted
Feb 2014
Primary outcome: Primary: TOF 0.9 Achieving Time — 1.6; 2.1 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- placebo (Drug); Magnesium Sulphate (Drug); sugammadex (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kocaeli University
- Primary completion
- Dec 2013
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 |
— | — |
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.
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
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.