NCT01972659

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Kocaeli University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Pre-eclampsia Aggravated

Interventions

Type	Name	Description
DRUG	placebo	Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
DRUG	Magnesium Sulphate	Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion
DRUG	sugammadex	4 mg/kg iv bolus at the end of the surgery

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-10-30
• Last updated: 2014-02-25
• Results posted: 2014-02-25

Locations

1 site across 1 country: Turkey (Türkiye)