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

Phase 4

Completed

Brief 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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
sugammadex and placebo	placebo	sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
sugammadex and placebo	sugammadex	sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
sugammadex and magnesium sulphate	Magnesium Sulphate	sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
sugammadex and magnesium sulphate	sugammadex	sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery