Trial Outcomes & Findings for the Impact of Noise on Requirements of Anesthetics During General Anesthesia (NCT NCT02534285)
NCT ID: NCT02534285
Last Updated: 2020-08-06
Results Overview
Aimed BIS-index is 50, desflurane is measured in expiratory volume percentage
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
one hour
Results posted on
2020-08-06
Participant Flow
Recruitment period from 09-04-2015 until 11-22-2016
Participant milestones
| Measure |
Control
Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.
hearing protection: Attenuation of hearing during surgery
|
Intervention
Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.
hearing protection: Attenuation of hearing during surgery
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
the Impact of Noise on Requirements of Anesthetics During General Anesthesia
Baseline characteristics by cohort
| Measure |
Control
n=50 Participants
Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.
hearing protection: Attenuation of hearing during surgery
|
Intervention
n=50 Participants
Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.
hearing protection: Attenuation of hearing during surgery
|
Total
n=100 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
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 9 • n=5 Participants
|
66 years
STANDARD_DEVIATION 10 • n=7 Participants
|
66 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one hourAimed BIS-index is 50, desflurane is measured in expiratory volume percentage
Outcome measures
| Measure |
Control
n=50 Participants
Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.
hearing protection: Attenuation of hearing during surgery
|
Intervention
n=50 Participants
Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.
hearing protection: Attenuation of hearing during surgery
|
|---|---|---|
|
Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia
|
3.6 Desflurane (Vol%)
Standard Deviation 1.2
|
3.7 Desflurane (Vol%)
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 1 dayUsing a structured interview ("modified Brice questionnaire") to detect episodes of intraoperative awareness
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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
Prof. Dr. Matthias Hübler
Technical University Dresden, Dept. of Anaesthesiology
Phone: +4945814002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place