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

Primary Purpose

Pre-eclampsia Aggravated

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
placebo
Magnesium Sulphate
sugammadex
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-eclampsia Aggravated focused on measuring sugammadex, rocuronium, magnesium, female

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Kocaeli University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

sugammadex and placebo

sugammadex and magnesium sulphate

Arm 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

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

Outcomes

Primary Outcome Measures

TOF 0.9 Achieving Time

Secondary Outcome Measures

Rocuronium Onset Time
Rocuronium Supplementation
Postoperative Morphine Consumption

Full Information

First Posted
October 11, 2013
Last Updated
January 10, 2014
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT01972659
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia Aggravated
Keywords
sugammadex, rocuronium, magnesium, female

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sugammadex and placebo
Arm Type
Active Comparator
Arm 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
Arm Title
sugammadex and magnesium sulphate
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
%0.9 NaCl, isotonic saline
Intervention Description
Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulphate
Other Intervention Name(s)
magnesium
Intervention Description
Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion
Intervention Type
Drug
Intervention Name(s)
sugammadex
Other Intervention Name(s)
bridion
Intervention Description
4 mg/kg iv bolus at the end of the surgery
Primary Outcome Measure Information:
Title
TOF 0.9 Achieving Time
Time Frame
end of the surgery
Secondary Outcome Measure Information:
Title
Rocuronium Onset Time
Time Frame
during the surgery
Title
Rocuronium Supplementation
Time Frame
during surgery
Title
Postoperative Morphine Consumption
Time Frame
after 12 hour surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra I. ARSLAN, Asst. Prof.
Organizational Affiliation
Anesthesiology and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University Hospital
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

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

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