Trial Outcomes & Findings for Using the SEDLine for the Titration of Sevoflurane in Elderly Patients Recovery Using the SEDLine TM for the Titration of Sevoflurane in Elderly Patients Undergoing Non-Cardiac Surgery After Beta-Adrenergic Blockade (NCT NCT00938782)
NCT ID: NCT00938782
Last Updated: 2015-02-19
Results Overview
The exact time from end of last anesthetic drug to time of tracheal extubation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
67 participants
Primary outcome timeframe
Measured from time of end anesthesia to time of tracheal extubation.
Results posted on
2015-02-19
Participant Flow
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups.
Participant milestones
| Measure |
1 - SEDLine™ Group
Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
|
2- Control Group
Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
35
|
|
Overall Study
COMPLETED
|
32
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using the SEDLine for the Titration of Sevoflurane in Elderly Patients Recovery Using the SEDLine TM for the Titration of Sevoflurane in Elderly Patients Undergoing Non-Cardiac Surgery After Beta-Adrenergic Blockade
Baseline characteristics by cohort
| Measure |
1 - SEDLine™ Group
n=32 Participants
Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was based on SEDLine™ data (SEDLine™ group).
|
2 - CONTROL Group
n=35 Participants
Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was not based on SEDLine™ data (CONTROL group)
|
Total
n=67 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
74.5 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
74.8 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured from time of end anesthesia to time of tracheal extubation.Population: All patients enrolled in both groups.
The exact time from end of last anesthetic drug to time of tracheal extubation.
Outcome measures
| Measure |
1 - Sedline Group
n=32 Participants
Patient group randomized to active monitoring with Sedline monitor.
|
2 - Control Group
n=35 Participants
Patient groups randomized to active monitoring versus blinded monitoring. This group had teh clinician blinded to output of the Sedline monitor.
|
|---|---|---|
|
Time to Extubation
|
13.0 minutes
Standard Deviation 5.9
|
12.5 minutes
Standard Deviation 7.4
|
Adverse Events
1 - SEDLine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 - Control Group
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