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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Patients of the control group receive a Sham hearing protection with no effect on noise attenuation. |
|
| Intervention | Active Comparator | Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hearing protection | Device | Attenuation of hearing during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one hour |
| Measure | Description | Time Frame |
|---|---|---|
| Awareness Using a Structured Interview ("Modified Brice Questionnaire") | Using a structured interview ("modified Brice questionnaire") to detect episodes of intraoperative awareness | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Hübler, MD | Consultant Dept. of Anesthesia; University Hospital Dresden; Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Dept. of Anesthesia | Dresden | 01307 | Germany |
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| Label | URL |
|---|---|
| Link to the published manuscript (open access). | View source |
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Recruitment period from 09-04-2015 until 11-22-2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients of the control group receive a Sham hearing protection with no effect on noise attenuation. hearing protection: Attenuation of hearing during surgery |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients of the control group receive a Sham hearing protection with no effect on noise attenuation. hearing protection: Attenuation of hearing during surgery |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | Desflurane (Vol%) | one hour |
|
14 months
No adverse events were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients of the control group receive a Sham hearing protection with no effect on noise attenuation. hearing protection: Attenuation of hearing during surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Matthias Hübler | Technical University Dresden, Dept. of Anaesthesiology | +4945814002 | matthias.huebler@uniklinikum-dresden.de |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.
hearing protection: Attenuation of hearing during surgery
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Awareness Using a Structured Interview ("Modified Brice Questionnaire") | Using a structured interview ("modified Brice questionnaire") to detect episodes of intraoperative awareness | Not Posted | 1 day | Participants |
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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 | 0 | 50 | 0 | 50 | 0 | 50 |
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