Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2014-07-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Isotonic serum
placebo administration
placebo administration
midazolam intravenous administration
Midazolam
midazolam intravenous administration 0.02mg/kg
placebo administration
midazolam intravenous administration
Interventions
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placebo administration
midazolam intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anesthesia state 1 and 2
* preoperative fasting for 6 hours
* information and signed consent
* social security
* non pregnant women
Exclusion Criteria
* midazolam sensibility
* pregnant or breastfeeding women
* ICU patients
* no consent
* pediatric surgery
* no social security
* no tracheal intubation
* required premedication in placebo group or midazolam sensibility in premedication group
18 Years
79 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Elise Blondé-Zoonekynd, Physician
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Emergency, University Hopital
Lille, , France
Countries
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References
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Sun GC, Hsu MC, Chia YY, Chen PY, Shaw FZ. Effects of age and gender on intravenous midazolam premedication: a randomized double-blind study. Br J Anaesth. 2008 Nov;101(5):632-9. doi: 10.1093/bja/aen251. Epub 2008 Sep 4.
Vogelsang J. The Visual Analog Scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs. 1988 Aug;3(4):235-9. No abstract available.
Bauer KP, Dom PM, Ramirez AM, O'Flaherty JE. Preoperative intravenous midazolam: benefits beyond anxiolysis. J Clin Anesth. 2004 May;16(3):177-83. doi: 10.1016/j.jclinane.2003.07.003.
Jerjes W, Jerjes WK, Swinson B, Kumar S, Leeson R, Wood PJ, Kattan M, Hopper C. Midazolam in the reduction of surgical stress: a randomized clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):564-70. doi: 10.1016/j.tripleo.2005.02.087.
Wattier JM, Barreau O, Devos P, Prevost S, Vallet B, Lebuffe G. [Measure of preoperative anxiety and need for information with six issues]. Ann Fr Anesth Reanim. 2011 Jul-Aug;30(7-8):533-7. doi: 10.1016/j.annfar.2011.03.010. Epub 2011 May 23. French.
Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
Reves JG, Fragen RJ, Vinik HR, Greenblatt DJ. Midazolam: pharmacology and uses. Anesthesiology. 1985 Mar;62(3):310-24.
Zalunardo MP, Ivleva-Sauerborn A, Seifert B, Spahn DR. [Quality of premedication and patient satisfaction after premedication with midazolam, clonidine or placebo : Randomized double-blind study with age-adjusted dosage]. Anaesthesist. 2010 May;59(5):410-8. doi: 10.1007/s00101-010-1695-9. German.
Other Identifiers
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PROM 2012_30
Identifier Type: OTHER
Identifier Source: secondary_id
2014-000873-38
Identifier Type: -
Identifier Source: org_study_id
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