Anesthesia
Conditions
Keywords
Anesthesia, Inhalation, Hearing, Noise, Occupational
Brief summary
The investigators hypothesize that the noise level in the operating theatre influences the patients' requirements of anesthetics. Study subject are patients undergoing abdominal surgery in combined general and epidural anesthesia. Analgesia is maintained by epidural injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the inhalational anesthetic desflurane. Desflurane requirements are adjusted using neuromonitoring (BIS-Index). Intraoperative noise levels are recorded. Patients are randomized to receive hearing protections or not.
Detailed description
All patients receive standardized anesthesia and monitoring according to the usual clinical care in the department. Placement of epidural catheters takes place before induction of general anesthesia. Thereafter, 10 ml ropivacaine 0.3% with 10 µg sufentanil are administered epidurally every 60 min to induce and maintain analgesia during surgery. Following induction of general anesthesia and tracheal Intubation, intraoperative hypnosis is maintained using desflurane.
Interventions
DEVICEhearing protection
Attenuation of hearing during surgery
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* full contractual capability * written informed consent * abdominal surgery in combined general/epidural anesthesia * position during surgery: supine * clinically normal hearing
Exclusion criteria
* history of psychiatric disease * history of intraoperative awareness * clinically impaired Hearing * contraindication for placing an epidural catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia | one hour | Aimed BIS-index is 50, desflurane is measured in expiratory volume percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Awareness Using a Structured Interview (Modified Brice Questionnaire) | 1 day | Using a structured interview (modified Brice questionnaire) to detect episodes of intraoperative awareness |
Countries
Germany
Participant flow
Recruitment details
Recruitment period from 09-04-2015 until 11-22-2016
Participants by arm
| Arm | Count |
|---|---|
| Control Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.
hearing protection: Attenuation of hearing during surgery | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 33 Participants | 61 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 17 Participants | 39 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 9 | 66 years STANDARD_DEVIATION 9 |
| Region of Enrollment Germany | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 47 Participants | 46 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia
Aimed BIS-index is 50, desflurane is measured in expiratory volume percentage
Time frame: one hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 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 |
| Intervention | Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia | 3.7 Desflurane (Vol%) | Standard Deviation 1 |
Secondary
Awareness Using a Structured Interview (Modified Brice Questionnaire)
Using a structured interview (modified Brice questionnaire) to detect episodes of intraoperative awareness
Time frame: 1 day