Trial Outcomes & Findings for Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients (NCT NCT01972659)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

end of the surgery

Results posted on

2014-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	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 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 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 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
Overall Study STARTED	40	40
Overall Study COMPLETED	36	37
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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 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 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 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
Overall Study Protocol Violation	2	2
Overall Study problems realted to acceleromyograph	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex and Placebo n=36 Participants 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 and Magnesium Sulphate n=37 Participants 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 n=73 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 10.3 • n=5 Participants	39.4 years STANDARD_DEVIATION 10.6 • n=7 Participants	40.1 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: end of the surgery

Outcome measures

Outcome measures
Measure	Sugammadex and Placebo n=36 Participants 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 and Magnesium Sulphate n=37 Participants 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
TOF 0.9 Achieving Time	1.6 minutes Standard Deviation 0.6	2.1 minutes Standard Deviation 0.9

SECONDARY outcome

Timeframe: during the surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: during surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after 12 hour surgery

Outcome measures

Outcome data not reported

Adverse Events

Sugammadex and Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugammadex and Magnesium Sulphate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Professor Dr Z Ipek ARSLAN AYDIN

Kocaeli University Medical Faculty

Phone: 00905325011339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place