Trial Outcomes & Findings for Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile (NCT NCT02243943)

Results Overview

Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

45 minutes post surgery

Results posted on

2017-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Sugammadex Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Sugammadex	Neostigmine subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Neostigmine
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex n=50 Participants Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Sugammadex	Neostigmine n=50 Participants subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Neostigmine	Total n=100 Participants Total of all reporting groups
Age, Continuous	55 years of age n=5 Participants	55 years of age n=7 Participants	55 years of age n=5 Participants
Gender Female	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Gender Male	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: 45 minutes post surgery

Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery

Outcome measures

Outcome measures
Measure	Sugammadex n=50 Participants Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Sugammadex	Neostigmine n=50 Participants subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Neostigmine
Mean Lowest Saturation	96.8 percentage of oxygen saturation Interval 96.1 to 97.4	93.3 percentage of oxygen saturation Interval 91.9 to 94.7

SECONDARY outcome

Timeframe: 45 minutes post surgery

using the 1-10 numeric rating scale

Outcome measures

Outcome measures
Measure	Sugammadex n=50 Participants Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Sugammadex	Neostigmine n=50 Participants subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Neostigmine
Pain	3.0 Numeric rating scale. 1(low)-10(maximum) Interval 2.3 to 3.7	3.2 Numeric rating scale. 1(low)-10(maximum) Interval 2.4 to 4.0

SECONDARY outcome

Timeframe: 45 minutes post surgery

using the Leiden observer alertness score (1 alert - 5 sedated)

Outcome measures

Outcome measures
Measure	Sugammadex n=50 Participants Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Sugammadex	Neostigmine n=50 Participants subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Neostigmine
Sedation	1.4 sedation scale (1 alert - 5 sedated) Interval 1.2 to 1.6	1.4 sedation scale (1 alert - 5 sedated) Interval 1.2 to 1.6

Adverse Events

Sugammadex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neostigmine

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

Prof Dr A. Dahan

LUMC

Phone: +31 71 526 2301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place