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

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ClinicalTrials.gov Identifier: NCT01972659
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Zehra Ipek ARSLAN, Kocaeli University

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.


Condition or disease Intervention/treatment Phase
Pre-eclampsia Aggravated Drug: placebo Drug: Magnesium Sulphate Drug: sugammadex Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
Active Comparator: sugammadex and 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
Drug: placebo
Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
Other Names:
  • %0.9 NaCl
  • isotonic saline

Drug: sugammadex
4 mg/kg iv bolus at the end of the surgery
Other Name: bridion

Experimental: sugammadex and 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
Drug: Magnesium Sulphate

Experimental :

50 mg/kg bolus plus 15 mg/kg continuous infusion

Other Name: magnesium

Drug: sugammadex
4 mg/kg iv bolus at the end of the surgery
Other Name: bridion




Primary Outcome Measures :
  1. TOF 0.9 Achieving Time [ Time Frame: end of the surgery ]

Secondary Outcome Measures :
  1. Rocuronium Onset Time [ Time Frame: during the surgery ]
  2. Rocuronium Supplementation [ Time Frame: during surgery ]
  3. Postoperative Morphine Consumption [ Time Frame: after 12 hour surgery ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972659


Locations
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Turkey
Kocaeli University Hospital
Kocaeli, Turkey, 41380
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Zehra I. ARSLAN, Asst. Prof. Anesthesiology and Reanimation

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Responsible Party: Zehra Ipek ARSLAN, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT01972659     History of Changes
Other Study ID Numbers: KOU 2012 KAEK 144
First Posted: October 30, 2013    Key Record Dates
Results First Posted: February 25, 2014
Last Update Posted: February 25, 2014
Last Verified: January 2014

Keywords provided by Zehra Ipek ARSLAN, Kocaeli University:
sugammadex
rocuronium
magnesium
female

Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Rocuronium
Magnesium Sulfate
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents