Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Information source: Kocaeli University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pre-eclampsia Aggravated
Intervention: placebo (Drug); Magnesium Sulphate (Drug); sugammadex (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Kocaeli University Official(s) and/or principal investigator(s):
Zehra I. ARSLAN, Asst. Prof., Principal Investigator, Affiliation: Anesthesiology and Reanimation
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.
Clinical Details
Official title: Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: TOF 0.9 Achieving Time
Secondary outcome: Rocuronium Onset TimeRocuronium Supplementation Postoperative Morphine Consumption
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Female.
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
Locations and Contacts
Kocaeli University Hospital, Kocaeli 41380, Turkey
Additional Information
Starting date: October 2012
Last updated: January 10, 2014
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