Trial Outcomes & Findings for Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981) (NCT NCT01479764)

Last Updated: 2017-06-06

Results Overview

Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth 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 NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of \<0.9 is indicative of residual NMB.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

154 participants

Primary outcome timeframe

At PACU entry on Day 1

Results posted on

2017-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Sugammadex Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery	Neostigmine/Glycopyrrolate Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Randomized STARTED	76	78
Randomized COMPLETED	74	77
Randomized NOT COMPLETED	2	1
Treated STARTED	74	77
Treated COMPLETED	74	75
Treated NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugammadex Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery	Neostigmine/Glycopyrrolate Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Randomized Adverse Event	1	1
Randomized Withdrawal by Subject	1	0
Treated Lost to Follow-up	0	2

Baseline Characteristics

Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex n=74 Participants Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery	Neostigmine/Glycopyrrolate n=77 Participants Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice	Total n=151 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 12.8 • n=5 Participants	57.0 years STANDARD_DEVIATION 12.7 • n=7 Participants	56.7 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: At PACU entry on Day 1

Population: The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate) and had a reliable TOF measurement at PACU entry.

Outcome measures

Outcome measures
Measure	Sugammadex n=74 Participants Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery	Neostigmine/Glycopyrrolate n=76 Participants Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry	0 participants	33 participants

SECONDARY outcome

Timeframe: Day 1

Population: The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).

The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.

Outcome measures

Outcome measures
Measure	Sugammadex n=74 Participants Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery	Neostigmine/Glycopyrrolate n=77 Participants Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Time From Start of Study Drug Administration to Operating Room Discharge-ready	15.02 minutes Interval 13.23 to 17.05	18.05 minutes Interval 15.94 to 20.43

Adverse Events

Sugammadex

Serious events: 7 serious events

Other events: 18 other events

Deaths: 0 deaths

Neostigmine/Glycopyrrolate

Serious events: 8 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Sugammadex n=74 participants at risk Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery	Neostigmine/Glycopyrrolate n=77 participants at risk Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Cardiac disorders Bradycardia	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	5.2% 4/77 • Number of events 4 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Cardiac disorders Tachycardia	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	5.2% 4/77 • Number of events 5 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Gastrointestinal disorders Nausea	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	5.2% 4/77 • Number of events 4 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Gastrointestinal disorders Vomiting	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	5.2% 4/77 • Number of events 4 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
General disorders Pyrexia	8.1% 6/74 • Number of events 6 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	7.8% 6/77 • Number of events 7 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Vascular disorders Hypertension	13.5% 10/74 • Number of events 10 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	2.6% 2/77 • Number of events 2 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Vascular disorders Hypotension	5.4% 4/74 • Number of events 4 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	7.8% 6/77 • Number of events 6 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).

Additional Information

Vice President, Late Stage Development Group Leader

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication and slides and texts of oral or other presentations that report any results of the trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Sugammadex n=74 participants at risk Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery	Neostigmine/Glycopyrrolate n=77 participants at risk Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Cardiac disorders Acute myocardial infarction	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Gastrointestinal disorders Diarrhoea	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Gastrointestinal disorders Gastronintestinal haemorrhage	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Gastrointestinal disorders Ileus	4.1% 3/74 • Number of events 3 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	3.9% 3/77 • Number of events 3 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Gastrointestinal disorders Ileus paralytic	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	0.00% 0/77 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Gastrointestinal disorders Nausea	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Gastrointestinal disorders Vomiting	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
General disorders Pyrexia	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	0.00% 0/77 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Infections and infestations Pneumonia	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Infections and infestations Wound infection	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Injury, poisoning and procedural complications Delayed recovery from anaesthesia	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Injury, poisoning and procedural complications Post procedural haemorrhage	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	0.00% 0/77 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Injury, poisoning and procedural complications Post procedural myocardial infarction	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	0.00% 0/77 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	0.00% 0/77 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Psychiatric disorders Delirium	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	0.00% 0/77 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Renal and urinary disorders Urinary retention	0.00% 0/74 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	1.3% 1/77 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Vascular disorders Haemorrhage	1.4% 1/74 • Number of events 1 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).	0.00% 0/77 • Up to 7 days after administration of study drug Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).