Trial Outcomes & Findings for Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101) (NCT NCT01050543)

Results Overview

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (height) of the 1st \& 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated complete recovery.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

128 participants

Primary outcome timeframe

From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Sugammadex sugammadex 2 mg/kg	Neostigmine neostigmine 50 mcg/kg
Overall Study STARTED	64	64
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugammadex sugammadex 2 mg/kg	Neostigmine neostigmine 50 mcg/kg
Overall Study Withdrawal by Subject	0	2
Overall Study Protocol Violation	0	1
Overall Study Administrative	4	1

Baseline Characteristics

Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex n=60 Participants sugammadex 2 mg/kg	Neostigmine n=60 Participants neostigmine 50 mcg/kg	Total n=120 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 14.0 • n=5 Participants	42.6 years STANDARD_DEVIATION 14.0 • n=7 Participants	42.0 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)

Population: Full Analysis Set, defined as all participants who received randomized treatment and had at least one efficacy measurement.

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (height) of the 1st \& 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated complete recovery.

Outcome measures

Outcome measures
Measure	Sugammadex n=59 Participants sugammadex 2 mg/kg	Neostigmine n=59 Participants neostigmine 50 mcg/kg
Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9	1.77 minutes Interval 1.57 to 2.01	14.80 minutes Interval 12.43 to 17.62

Adverse Events

Sugammadex

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Neostigmine

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sugammadex n=60 participants at risk sugammadex 2 mg/kg	Neostigmine n=60 participants at risk neostigmine 50 mcg/kg
Infections and infestations Post-operative abscess	1.7% 1/60 • Number of events 1	0.00% 0/60
Injury, poisoning and procedural complications Intestinal anastomosis complication	1.7% 1/60 • Number of events 1	0.00% 0/60
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/60	1.7% 1/60 • Number of events 1
Renal and urinary disorders Dysuria	0.00% 0/60	1.7% 1/60 • Number of events 1

Other adverse events

Other adverse events
Measure	Sugammadex n=60 participants at risk sugammadex 2 mg/kg	Neostigmine n=60 participants at risk neostigmine 50 mcg/kg
Gastrointestinal disorders Nausea	6.7% 4/60 • Number of events 4	6.7% 4/60 • Number of events 4
Injury, poisoning and procedural complications Incision site pain	11.7% 7/60 • Number of events 9	20.0% 12/60 • Number of events 16
Injury, poisoning and procedural complications Procedural hypotension	6.7% 4/60 • Number of events 6	1.7% 1/60 • Number of events 2
Injury, poisoning and procedural complications Procedural pain	33.3% 20/60 • Number of events 22	30.0% 18/60 • Number of events 19
Injury, poisoning and procedural complications Wound complication	5.0% 3/60 • Number of events 3	10.0% 6/60 • Number of events 6
Nervous system disorders Headache	11.7% 7/60 • Number of events 8	15.0% 9/60 • Number of events 10

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor shall have the right to review and comment with respect to publications with regard to the following concerns: proprietary information; accuracy of the information; and to ensure that the presentation is fairly balanced and in compliance with FDA regulations. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
Publication restrictions are in place

Restriction type: OTHER