Trial Outcomes & Findings for Comparison of Time to Extubation Using Sugammadex or Neostigmine (NCT NCT04606901)

NCT ID: NCT04606901

Last Updated: 2024-03-13

Results Overview

number of minutes from reversal dose to Train of Four (TOF) \>0.9 indicating full reversal of neuromuscular blockade agent

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 58 participants
• Primary outcome timeframe: 1-20 minutes
• Results posted on: 2024-03-13

Participant Flow

Participant milestones

Measure	Sugammadex Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. sugammadex: neuromuscular blockade reversal agent	Neostigmine/Glycopyrrolate Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade neostigmine/glycopyrrolate: neuromuscular blockade reversal agents
Overall Study STARTED	28	30
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Time to Extubation Using Sugammadex or Neostigmine

Baseline characteristics by cohort

Measure	Sugammadex n=28 Participants Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. sugammadex: neuromuscular blockade reversal agent	Neostigmine/Glycopyrrolate n=30 Participants Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade neostigmine/glycopyrrolate: neuromuscular blockade reversal agents	Total n=58 Participants Total of all reporting groups
Age, Continuous	66.6 years STANDARD_DEVIATION 8.7 • n=5 Participants	65.0 years STANDARD_DEVIATION 8.8 • n=7 Participants	65.8 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-20 minutes

number of minutes from reversal dose to Train of Four (TOF) >0.9 indicating full reversal of neuromuscular blockade agent

Outcome measures

Measure	Sugammadex n=28 Participants Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. sugammadex: neuromuscular blockade reversal agent	Neostigmine/Glycopyrrolate n=30 Participants Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade neostigmine/glycopyrrolate: neuromuscular blockade reversal agents
Number of Minutes to Return of Baseline Muscle Tone	3.9 minutes Standard Deviation 2.0	12.9 minutes Standard Deviation 9.8

SECONDARY outcome

Timeframe: 1-30 minutes

number of minutes from Train of Four (TOF) >0.9 to extubation of the patient

Outcome measures

Measure	Sugammadex n=28 Participants Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. sugammadex: neuromuscular blockade reversal agent	Neostigmine/Glycopyrrolate n=30 Participants Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade neostigmine/glycopyrrolate: neuromuscular blockade reversal agents
Number of Minutes to Extubation	11.9 minutes Standard Deviation 8.3	17.7 minutes Standard Deviation 10.5

Adverse Events

Sugammadex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neostigmine/Glycopyrrolate

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

Dr. Ellen Hauck

Temple University Hospital

Phone: 2674438719

Email: ellen.hauck@tuhs.temple.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place