Trial Outcomes & Findings for Comparision of Different Dose of Neostigmine at Advanced Decurarization (NCT NCT00847938)

Last Updated: 2019-05-29

Results Overview

train-of-four monitoring (also known as neuromuscular monitoring), is a technique used during recovery from the application of general anesthesia to objectively determine how well a patient's muscles are able to function, by recording muscle response after nerves electrical stimulation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

62 participants

Primary outcome timeframe

from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour

Results posted on

2019-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Neostigmine 40 µg/kg neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Neostigmine 20 µg/kg neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Neostigmine 10 µg/kg neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Placebo no injection of neostigmine
Overall Study STARTED	16	15	16	15
Overall Study COMPLETED	16	14	15	15
Overall Study NOT COMPLETED	0	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparision of Different Dose of Neostigmine at Advanced Decurarization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neostigmine 40 µg/kg n=16 Participants neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Neostigmine 20 µg/kg n=14 Participants neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Neostigmine 10 µg/kg n=15 Participants neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Placebo n=15 Participants no injection of neostigmine	Total n=60 Participants Total of all reporting groups
Age, Continuous	50.7 years STANDARD_DEVIATION 17.6 • n=5 Participants	51.9 years STANDARD_DEVIATION 18.1 • n=7 Participants	60.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	50.6 years STANDARD_DEVIATION 14.8 • n=4 Participants	53.3 years STANDARD_DEVIATION 16.0 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	9 Participants n=4 Participants	38 Participants n=21 Participants
BMI	23.9 kg/m² STANDARD_DEVIATION 3.6 • n=5 Participants	25.4 kg/m² STANDARD_DEVIATION 3.7 • n=7 Participants	26.9 kg/m² STANDARD_DEVIATION 4.0 • n=5 Participants	26.9 kg/m² STANDARD_DEVIATION 3.3 • n=4 Participants	25.7 kg/m² STANDARD_DEVIATION 3.8 • n=21 Participants
ASA Physical Status Classification System ASA I	8 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
ASA Physical Status Classification System ASA II	8 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	39 Participants n=21 Participants
ASA Physical Status Classification System ASA III	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
surgery time	80.2 minute STANDARD_DEVIATION 40.4 • n=5 Participants	75.8 minute STANDARD_DEVIATION 32.4 • n=7 Participants	84.1 minute STANDARD_DEVIATION 54.9 • n=5 Participants	78.1 minute STANDARD_DEVIATION 44.3 • n=4 Participants	79.6 minute STANDARD_DEVIATION 43.9 • n=21 Participants

PRIMARY outcome

Timeframe: from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour

Outcome measures

Outcome measures
Measure	Neostigmine 40 µg/kg n=16 Participants neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Neostigmine 20 µg/kg n=14 Participants neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Neostigmine 10 µg/kg n=15 Participants neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	Placebo n=15 Participants no injection of neostigmine
Mesure of the Train-of-four (TOF) recovery time to TOF ratio of 0.9	3.8 minute Interval 2.3 to 7.0	4.5 minute Interval 2.5 to 8.0	11.5 minute Interval 3.8 to 17.5	19 minute Interval 10.5 to 36.0
Mesure of the Train-of-four (TOF) recovery time to TOF ratio of 1.0	5.5 minute Interval 4.0 to 11.0	7.8 minute Interval 3.5 to 11.0	17 minute Interval 7.0 to 55.0	26 minute Interval 20.0 to 50.0

Adverse Events

Neostigmine 40 µg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neostigmine 20 µg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neostigmine 10 µg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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 Florent CAPRON

Clinique Jules Verne

Phone: 0251171775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place