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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pre-eclampsia Aggravated

Intervention / Treatment
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* Drug: placebo
* Drug: Magnesium Sulphate
* Drug: sugammadex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sugammadex and placebo<br>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 | Drug: placebo<br>* Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion<br>* Other names: isotonic saline;Drug: sugammadex<br>* 4 mg/kg iv bolus at the end of the surgery<br>* Other names: bridion;|
| Experimental: sugammadex and magnesium sulphate<br>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 | Drug: Magnesium Sulphate<br>* Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion<br>* Other names: magnesium;Drug: sugammadex<br>* 4 mg/kg iv bolus at the end of the surgery<br>* Other names: bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOF 0.9 Achieving Time |  | end of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rocuronium Onset Time |  | during the surgery | 
| Rocuronium Supplementation |  | during surgery | 
| Postoperative Morphine Consumption |  | after 12 hour surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rocuronium, sugammadex, magnesium, female