Trial Outcomes & Findings for The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade (NCT NCT01545193)
NCT ID: NCT01545193
Last Updated: 2019-09-16
Results Overview
The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios \< 0.9 in each group will be compared.
COMPLETED
300 participants
Early postoperative period, up to 24 hours
2019-09-16
Participant Flow
Participant milestones
| Measure |
Age 18-50
This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
Age 70-90
This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
150
|
149
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade
Baseline characteristics by cohort
| Measure |
Age 18-50
n=150 Participants
This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
Age 70-90
n=149 Participants
This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
Total
n=299 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
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
n=5 Participants
|
75 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
149 participants
n=7 Participants
|
299 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Early postoperative period, up to 24 hoursThe TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios \< 0.9 in each group will be compared.
Outcome measures
| Measure |
Age 18-50
n=150 Participants
This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
Age 70-90
n=149 Participants
This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
|---|---|---|
|
Incidence of Residual Neuromuscular Blockade
|
45 participants
|
86 participants
|
SECONDARY outcome
Timeframe: Early postoperative period, up to 24 hoursA standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission. Reported data is the total number of symptoms (0-16) at PACU admission
Outcome measures
| Measure |
Age 18-50
n=150 Participants
This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
Age 70-90
n=149 Participants
This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
|---|---|---|
|
Signs and Symptoms of Residual Neuromuscular Blockade
|
2 symptoms
Interval 0.0 to 5.0
|
4 symptoms
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: Early postoperative period, up to 24 hoursPulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Data reported are the number of patients developing hypoxemia (oxygen saturation \< 94% on pulse oximetry) in the PACU
Outcome measures
| Measure |
Age 18-50
n=150 Participants
This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
Age 70-90
n=149 Participants
This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
|---|---|---|
|
Respiratory Events Potentially Related to Residual Neuromuscular Blockade
|
26 participants
|
57 participants
|
SECONDARY outcome
Timeframe: Early postoperative period, up to 24 hoursThe time required to meet discharge criteria and achieve actual discharge will be noted.
Outcome measures
| Measure |
Age 18-50
n=150 Participants
This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
Age 70-90
n=149 Participants
This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
|
|---|---|---|
|
PACU Length of Stay
|
73 minutes
Interval 56.0 to 102.0
|
92 minutes
Interval 67.0 to 125.0
|
Adverse Events
Age 18-50
Age 70-90
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