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

Kocaeli University

Status and phase: Completed; Phase 4

Conditions: Pre-eclampsia Aggravated

Treatments: Drug: placebo; Drug: sugammadex; Drug: Magnesium Sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT01972659

KOU 2012 KAEK 144

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 2 patient groups

sugammadex and placebo

Active Comparator group

Description:

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

Treatment:

Drug: sugammadex

Drug: placebo

sugammadex and magnesium sulphate

Experimental group

Description:

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

Treatment:

Drug: Magnesium Sulphate

Drug: sugammadex