Clinical trial NCT01972659: Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Official title: Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pre-eclampsia Aggravated
Keywords: sugammadex
rocuronium
magnesium
female
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: TOF 0.9 Achieving Time
timeFrame: end of the surgery
Secondary outcomes:
measure: Rocuronium Onset Time
timeFrame: during the surgery
measure: Rocuronium Supplementation
timeFrame: during surgery
measure: Postoperative Morphine Consumption
timeFrame: after 12 hour surgery
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
Study officials:
affiliation: Anesthesiology and Reanimation
name: Zehra I. ARSLAN, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: