Trial Outcomes & Findings for Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028) (NCT NCT00559468)

Last Updated: 2019-11-25

Results Overview

Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \[loss of T4\] up to 1.0 \[no NMB\]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

52 participants

Primary outcome timeframe

Up to 3 minutes after sugammadex administration

Results posted on

2019-11-25

Participant Flow

Participants who had a surgical procedure using a general anesthesia (with sevoflurane or propofol) and rocuronium for endotracheal intubation and maintenance of neuromuscular block (NMB) were enrolled in this study.

Out of 52 randomized participants, 51 received treatment.

Participant milestones

Participant milestones
Measure	Sugammadex + Sevoflurane After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.	Sugammadex + Propofol After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
Overall Study STARTED	26	26
Overall Study Treated	26	25
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex + Sevoflurane n=26 Participants After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.	Sugammadex + Propofol n=25 Participants After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.	Total n=51 Participants Total of all reporting groups
Age, Continuous	49.8 Years STANDARD_DEVIATION 12.4 • n=5 Participants	50.4 Years STANDARD_DEVIATION 8.3 • n=7 Participants	50.1 Years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 minutes after sugammadex administration

Population: All randomized participants who received sugammadex and had at least one efficacy measurement.

Outcome measures

Outcome measures
Measure	Sugammadex + Sevoflurane n=26 Participants After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.	Sugammadex + Propofol n=25 Participants After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9	1.45 minutes Standard Deviation 0.45	1.32 minutes Standard Deviation 0.40

SECONDARY outcome

Timeframe: Up to 3 minutes after sugammadex administration

Population: All randomized participants who received sugammadex and had at least one efficacy measurement.

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \[loss of T4\] up to 1.0 \[no NMB\]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.7 indicates a faster recovery from NMB.

Outcome measures

Outcome measures
Measure	Sugammadex + Sevoflurane n=26 Participants After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.	Sugammadex + Propofol n=25 Participants After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7	1.07 minutes Standard Deviation 0.25	1.02 minutes Standard Deviation 0.28

SECONDARY outcome

Timeframe: Up to 3 minutes after sugammadex administration

Population: All randomized participants who received sugammadex and had at least one efficacy measurement.

Outcome measures

Outcome measures
Measure	Sugammadex + Sevoflurane n=26 Participants After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.	Sugammadex + Propofol n=25 Participants After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8	1.20 minutes Standard Deviation 0.35	1.12 minutes Standard Deviation 0.30

Adverse Events

Sugammadex + Sevoflurane

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Sugammadex + Propofol

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sugammadex + Sevoflurane n=26 participants at risk After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.	Sugammadex + Propofol n=25 participants at risk After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
Gastrointestinal disorders Constipation	46.2% 12/26 • Number of events 12 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	20.0% 5/25 • Number of events 5 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Gastrointestinal disorders Flatulence	15.4% 4/26 • Number of events 4 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	20.0% 5/25 • Number of events 5 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Gastrointestinal disorders Nausea	34.6% 9/26 • Number of events 11 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	20.0% 5/25 • Number of events 6 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Gastrointestinal disorders Vomiting	15.4% 4/26 • Number of events 4 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	8.0% 2/25 • Number of events 2 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
General disorders Impaired healing	7.7% 2/26 • Number of events 2 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	0.00% 0/25 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
General disorders Oedema peripheral	3.8% 1/26 • Number of events 1 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	8.0% 2/25 • Number of events 2 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
General disorders Pyrexia	7.7% 2/26 • Number of events 2 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	0.00% 0/25 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Injury, poisoning and procedural complications Procedural pain	53.8% 14/26 • Number of events 14 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	76.0% 19/25 • Number of events 21 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Metabolism and nutrition disorders Hypokalaemia	3.8% 1/26 • Number of events 1 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	8.0% 2/25 • Number of events 2 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Nervous system disorders Headache	7.7% 2/26 • Number of events 2 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	4.0% 1/25 • Number of events 1 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Nervous system disorders Hypoaesthesia	7.7% 2/26 • Number of events 2 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	0.00% 0/25 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Psychiatric disorders Insomnia	26.9% 7/26 • Number of events 9 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	8.0% 2/25 • Number of events 2 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.
Psychiatric disorders Sleep disorder	15.4% 4/26 • Number of events 4 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.	12.0% 3/25 • Number of events 3 • Up to 7 days after sugammadex treatment All randomized participants receiving study treatment are included.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor recognizes the right of the investigators to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Publication restrictions are in place

Restriction type: OTHER