Trial Outcomes & Findings for Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal (NCT NCT01915108)
NCT ID: NCT01915108
Last Updated: 2014-08-25
Results Overview
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.
Results posted on
2014-08-25
Participant Flow
Participant milestones
| Measure |
Group R0
remifentanil Ce of 0 ng/ml
|
Group R0.5
remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.0
remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.5
remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
30
|
29
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal
Baseline characteristics by cohort
| Measure |
Group R0
n=30 Participants
remifentanil Ce of 0 ng/ml
|
Group R0.5
n=29 Participants
remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.0
n=31 Participants
remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.5
n=30 Participants
remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Total
n=120 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
120 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.
Outcome measures
| Measure |
Group R0
n=30 Participants
remifentanil Ce of 0 ng/ml
|
Group R0.5
n=29 Participants
remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.0
n=31 Participants
remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.5
n=30 Participants
remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
|---|---|---|---|---|
|
Number of Patients With Adverse Events Following LMA Removal
|
10 participants
|
5 participants
|
1 participants
|
0 participants
|
Adverse Events
Group R0
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Group R1.5
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Group R0.5
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Group R1.0
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group R0
n=30 participants at risk
remifentanil Ce of 0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.5
n=30 participants at risk
remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R0.5
n=29 participants at risk
remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.0
n=31 participants at risk
remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
airway obstruction
|
3.3%
1/30 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
0.00%
0/31
|
Other adverse events
| Measure |
Group R0
n=30 participants at risk
remifentanil Ce of 0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.5
n=30 participants at risk
remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R0.5
n=29 participants at risk
remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
Group R1.0
n=31 participants at risk
remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
breath holding
|
43.3%
13/30 • Number of events 13
|
20.0%
6/30 • Number of events 6
|
48.3%
14/29 • Number of events 14
|
9.7%
3/31 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place