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

• Sponsor: Kocaeli University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01972659
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 5.7

Study Details

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.

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

Study Design

• Study Type: Interventional
• 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: Oct 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. TOF 0.9 Achieving Time [end of the surgery]

Secondary Outcome Measures

1. Rocuronium Onset Time [during the surgery]

2. Rocuronium Supplementation [during surgery]

3. Postoperative Morphine Consumption [after 12 hour surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University Hospital	Kocaeli		Turkey	41380

Sponsors and Collaborators

• Kocaeli University

Investigators

• Principal Investigator: Zehra I. ARSLAN, Asst. Prof., Anesthesiology and Reanimation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zehra Ipek ARSLAN, Assistant Professor, Kocaeli University
• ClinicalTrials.gov Identifier: NCT01972659
• Other Study ID Numbers: KOU 2012 KAEK 144
• First Posted: Oct 30, 2013
• Last Update Posted: Feb 25, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Zehra Ipek ARSLAN, Assistant Professor, Kocaeli University: sugammadex; rocuronium; magnesium; female
• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia; Magnesium Sulfate

Study Results

Participant Flow

Arm/Group Title	Sugammadex and Placebo	Sugammadex and Magnesium Sulphate
Arm/Group 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 placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the 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 Magnesium Sulphate: Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery
Period Title: Overall Study
STARTED	40	40
COMPLETED	36	37
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Sugammadex and Placebo	Sugammadex and Magnesium Sulphate	Total
Arm/Group 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 placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the 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 Magnesium Sulphate: Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery	Total of all reporting groups
Overall Participants	36	37	73
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.3 (10.3)	39.4 (10.6)	40.1 (10.4)
Sex: Female, Male (Count of Participants)
Female	36 100%	37 100%	73 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	TOF 0.9 Achieving Time
Time Frame	end of the surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugammadex and Placebo	Sugammadex and Magnesium Sulphate
Arm/Group 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 placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the 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 Magnesium Sulphate: Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery
Measure Participants	36	37
Mean (Standard Deviation) [minutes]	1.6 (0.6)	2.1 (0.9)

2. Secondary Outcome

Title	Rocuronium Onset Time
Time Frame	during the surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Rocuronium Supplementation
Time Frame	during surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Postoperative Morphine Consumption
Time Frame	after 12 hour surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Sugammadex and Placebo		Sugammadex and Magnesium Sulphate
Arm/Group 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 placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the 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 Magnesium Sulphate: Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery
All Cause Mortality
	Sugammadex and Placebo		Sugammadex and Magnesium Sulphate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sugammadex and Placebo		Sugammadex and Magnesium Sulphate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Sugammadex and Placebo		Sugammadex and Magnesium Sulphate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.