Trial Outcomes & Findings for Effect of Neuromuscular Blockade and Reversal on Breathing (NCT NCT02845375)
NCT ID: NCT02845375
Last Updated: 2020-02-19
Results Overview
The change in breathing response to a decrease in inspired oxygen concentration, which equals the isocapnic ventilatory response to hypoxia.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
during the 1-2 hours following reversal
Results posted on
2020-02-19
Participant Flow
46 subjects were enrolled.6 did not meet inclusion citeria. 40 subjects were randomized
Participant milestones
| Measure |
PLACEBO
Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
NEOSTIGMINE
intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
SUGAMMADEX
intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
PLACEBO
Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
NEOSTIGMINE
intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
SUGAMMADEX
intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
|---|---|---|---|
|
Overall Study
upper airway obstruction
|
1
|
2
|
1
|
Baseline Characteristics
Effect of Neuromuscular Blockade and Reversal on Breathing
Baseline characteristics by cohort
| Measure |
PLACEBO
n=12 Participants
Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
NEOSTIGMINE
n=12 Participants
intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
SUGAMMADEX
n=12 Participants
intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
20 years
n=5 Participants
|
23 years
n=7 Participants
|
23 years
n=5 Participants
|
22 years
n=4 Participants
|
|
Sex: Female, Male
Sex · Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Sex · Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Breathing response to a reduction in inspired oxygen concentration (hypoxic ventilatory response)
|
0.66 L/min/% oxygen saturation
STANDARD_DEVIATION 0.21 • n=5 Participants
|
0.43 L/min/% oxygen saturation
STANDARD_DEVIATION 0.23 • n=7 Participants
|
0.54 L/min/% oxygen saturation
STANDARD_DEVIATION 0.16 • n=5 Participants
|
0.55 L/min/% oxygen saturation
STANDARD_DEVIATION 0.22 • n=4 Participants
|
PRIMARY outcome
Timeframe: during the 1-2 hours following reversalPopulation: Healthy male volunteers
The change in breathing response to a decrease in inspired oxygen concentration, which equals the isocapnic ventilatory response to hypoxia.
Outcome measures
| Measure |
PLACEBO
n=12 Participants
Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
NEOSTIGMINE
n=12 Participants
intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
SUGAMMADEX
n=12 Participants
intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
|---|---|---|---|
|
Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
Baseline
|
0.66 L/min/% desaturation
Standard Deviation 0.21
|
0.43 L/min/% desaturation
Standard Deviation 0.22
|
0.54 L/min/% desaturation
Standard Deviation 0.16
|
|
Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
Relaxation
|
0.34 L/min/% desaturation
Standard Deviation 0.22
|
0.29 L/min/% desaturation
Standard Deviation 0.22
|
0.31 L/min/% desaturation
Standard Deviation 0.17
|
|
Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
Reversal
|
0.49 L/min/% desaturation
Standard Deviation 0.13
|
0.36 L/min/% desaturation
Standard Deviation 0.20
|
0.31 L/min/% desaturation
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: 0-10 minutes following reversalPopulation: The ventilation-saturation data were analyzed using linear regreassion analysis. The slope is the acute hypoxic ventilatory response.
The ventilatory response to a decrease in oxygen saturaytion of 80%
Outcome measures
| Measure |
PLACEBO
n=12 Participants
Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
NEOSTIGMINE
n=12 Participants
intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
SUGAMMADEX
n=12 Participants
intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
|
|---|---|---|---|
|
Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
|
0.49 L/min/%
Standard Deviation 0.13
|
0.36 L/min/%
Standard Deviation 0.20
|
0.48 L/min/%
Standard Deviation 0.13
|
Adverse Events
PLACEBO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NEOSTIGMINE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SUGAMMADEX
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place