Trial Outcomes & Findings for Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex (NCT NCT01962298)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

75 participants

Primary outcome timeframe

From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing

Results posted on

2018-10-24

Participant Flow

Patients were screened for inclusion and approached the night prior to their elective surgery

Participant milestones

Participant milestones
Measure	Single Rocuronium Dose - Placebo The patients will receive a single rocuronium dose, and no reversal agent. placebo Single rocuronium dose	Single Rocuronium Dose - Sugammadex The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent sugammadex 2mg/kg Single rocuronium dose	Repeated Rocuronium Dose - Neostigmine The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent neostigmine Repeated rocuronium dose	Repeated Rocuronium Dose - Sugammadex The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent sugammadex 2mg/kg Repeated rocuronium dose	Continuous Rocuronium Dose The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion
Overall Study STARTED	15	15	15	15	15
Overall Study Received Intervention	14	15	15	15	15
Overall Study COMPLETED	12	11	10	13	9
Overall Study NOT COMPLETED	3	4	5	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Rocuronium Dose - Placebo The patients will receive a single rocuronium dose, and no reversal agent. placebo Single rocuronium dose	Single Rocuronium Dose - Sugammadex The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent sugammadex 2mg/kg Single rocuronium dose	Repeated Rocuronium Dose - Neostigmine The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent neostigmine Repeated rocuronium dose	Repeated Rocuronium Dose - Sugammadex The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent sugammadex 2mg/kg Repeated rocuronium dose	Continuous Rocuronium Dose The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion
Overall Study Protocol Violation	1	0	1	1	0
Overall Study Data quality insufficient	2	0	3	1	4
Overall Study Insufficient data	0	2	1	0	1
Overall Study Incorrect data recorded	0	1	0	0	0
Overall Study Physician Decision	0	1	0	0	1

Baseline Characteristics

Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Rocuronium Dose - Placebo n=12 Participants The patients will receive a single rocuronium dose, and no reversal agent. placebo Single rocuronium dose	Single Rocuronium Dose - Sugammadex n=11 Participants The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent sugammadex 2mg/kg Single rocuronium dose	Repeated Rocuronium Dose - Neostigmine n=10 Participants The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent neostigmine Repeated rocuronium dose	Repeated Rocuronium Dose - Sugammadex n=13 Participants The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent sugammadex 2mg/kg Repeated rocuronium dose	Continuous Rocuronium Dose n=9 Participants The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion	Total n=55 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	51 years n=7 Participants	56 years n=5 Participants	54 years n=4 Participants	55 years n=21 Participants	55 years n=10 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	33 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	22 Participants n=10 Participants
Body Mass Index	26 kg/m2 n=5 Participants	27 kg/m2 n=7 Participants	25 kg/m2 n=5 Participants	26 kg/m2 n=4 Participants	24 kg/m2 n=21 Participants	26 kg/m2 n=10 Participants

PRIMARY outcome

Timeframe: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing

Outcome measures

Outcome measures
Measure	Single Rocuronium Dose - Placebo n=12 Participants The patients will receive a single rocuronium dose, and no reversal agent. placebo Single rocuronium dose	Single Rocuronium Dose - Sugammadex n=11 Participants The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent sugammadex 2mg/kg Single rocuronium dose	Repeated Rocuronium Dose - Neostigmine n=10 Participants The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent neostigmine Repeated rocuronium dose	Repeated Rocuronium Dose - Sugammadex n=13 Participants The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent sugammadex 2mg/kg Repeated rocuronium dose	Continuous Rocuronium Dose n=9 Participants The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion
Electric Activity of the Diaphragm (Microvolts)	3.7 microvolt Interval 1.7 to 7.7	4.5 microvolt Interval 2.1 to 8.0	3.2 microvolt Interval 0.9 to 7.3	2.9 microvolt Interval 1.3 to 5.3	4.4 microvolt Interval 1.9 to 7.5

SECONDARY outcome

Timeframe: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing

Outcome measures

Outcome measures
Measure	Single Rocuronium Dose - Placebo n=12 Participants The patients will receive a single rocuronium dose, and no reversal agent. placebo Single rocuronium dose	Single Rocuronium Dose - Sugammadex n=11 Participants The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent sugammadex 2mg/kg Single rocuronium dose	Repeated Rocuronium Dose - Neostigmine n=10 Participants The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent neostigmine Repeated rocuronium dose	Repeated Rocuronium Dose - Sugammadex n=13 Participants The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent sugammadex 2mg/kg Repeated rocuronium dose	Continuous Rocuronium Dose n=9 Participants The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion
Electric Activity of the Intercostal Muscles	2.4 microvolt Interval 1.4 to 4.5	2.2 microvolt Interval 1.2 to 4.7	1.5 microvolt Interval 1.1 to 2.5	2.2 microvolt Interval 1.3 to 4.5	1.8 microvolt Interval 1.1 to 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of spontaneous breathing till extubation, limited to maximum one hour after the onset of spontaneous breathing