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Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.
The care system will not differ from the usually treatment of patients. Patients will decided about the type of anesthesia (local or general) after detailed description of both procedures.
All operations will be performed by the same surgeon and the same basic surgical technique.
The only difference is that patients included in thi study will have to complete a satisfactory survey 10 days after surgery and a GBI questionnaire 3 months after surgery, during the post operative consultations .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local anesthetic | Patients who chose local anesthesia for their surgery |
| |
| General anesthetic | Patients who chose general anesthesia for their surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthetic | Drug | 1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual comfort scale (EVA type ruler) | respondents specify their level of comfort during the surgery by indicating a position along a continuous line between two end-points : Minimum score is 0 (no comfort) and maximum is 10 (very comfortable) during surgery | 10 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Benefit Inventory questionnaire GBI | Glasgow Benefit Inventory questionnaire GBI (GBI, Robinson et al. 1996).
|
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Inclusion criteria:
Exclusion criteria:
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Patients suffering from otosclerosis who have surgical indication
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| Name | Affiliation | Role |
|---|---|---|
| Benoit Godey, PH-PD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Rennes | Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D010040 | Otosclerosis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D018681 | Anesthetics, General |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| general anesthetic | Drug | Endotracheal intubation, intravenous narcotic agents, and inhaled agents |
|
| 3 months after surgery |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |