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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002553-65 | EudraCT Number |
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The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.
double blind, randomized controlled study
Eligibility:
Outcome measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zopiclone | Experimental | zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery) |
|
| alprazolam | Experimental | given at awakening, the day of surgery (placebo given before sleep, the day before surgery) |
|
| placebo | Placebo Comparator | Placebo given night before operation and the morning of operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zopiclone | Drug | 7.5 mg before sleep, the evening before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| anxiety scales | * The day before surgery (late afternoon) : patient's self rating of anxiety and desire of information regarding upcoming surgery (Amsterdam patient anxiety and information scale, APAIS) * On arrival to the operating room : Recording of the level of declared anxiety (numeric scale similar to that corresponding of the "anxiety component of the APAIS scale) | duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating room) |
| Measure | Description | Time Frame |
|---|---|---|
| markers of stress | recording of actual (using the operating room monitor):
| on arrival to operating room (one single recording) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Beydon, MD | University Hospital Angers (Dept of Anesthesia) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Sévigné | Cesson | Brittany Region | 35576 | France | ||
| Dept of Anesthesia, Hôpital Maison Blanche |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26004882 | Derived | Beydon L, Rouxel A, Camut N, Schinkel N, Malinovsky JM, Aveline C, Marret E, Bildea A, Dupoiron D, Liu N, Daniel V, Darsonval A, Chretien JM, Rault L, Bruna J, Alberti C. Sedative premedication before surgery--A multicentre randomized study versus placebo. Anaesth Crit Care Pain Med. 2015 Jun;34(3):165-71. doi: 10.1016/j.accpm.2015.01.005. Epub 2015 May 23. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C515050 | zopiclone |
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Alprazolam | Drug | 0.5 mg at awakening, the day of surgery |
|
|
| placebo | Drug | given night before surgery and at awakening, the day of surgery |
|
| Reims |
| Champagne |
| 51092 |
| France |
| Centre Paul Papin | Angers | Maine et Loire | 49000 | France |
| University Hospital | Angers | Maine et Loire | 49933 | France |
| Clinique St Leonard | Trélazé | Maine et Loire | 49800 | France |
| Dept of Anesthesia | Le Mans | Maine | 72000 | France |
| Dept of Anesthesia, Hôpital Tenon | Paris | Île-de-France Region | 75020 | France |
| Dept of Anesthesia, Hôpital Foch, | Suresnes | Île-de-France Region | 92150 | France |
| D006571 | Heterocyclic Compounds |