Status:
COMPLETED
Sedative Premedication: Efficacy On Patient Experience
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Perioperative Anxiety
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Seven French university hospitals will participate in this multicentric prospective, blinded and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo (microcrystalline...
Eligibility Criteria
Inclusion
- male or female aged 18 to 70 years or more;
- About a weight greater than 45 kg;
- Subject to benefit from a scheduled surgery under general anesthesia;
- Topic respecting the ambivalence clause defined below:
- Having no cons-indication to the use of benzodiazepines;
- Having no known allergy to benzodiazepines;
- May be a candidate for the prescription of premedication;
- Topic able to complete a self-administered questionnaire;
- Subject has signed a written informed consent and agreeing to abide by the instructions of the Protocol
Exclusion
- \- Topic of over 70 years;
- Topic 45 kg or less;
- Topic demanding to receive anxiolytic premedication;
- Subject severe respiratory insufficiency;
- Topic minor, pregnant or breastfeeding, about not being affiliated to the social security system;
- Topic for which surgery is performed under local anesthesia;
- Subject unable to perform only a self-administered questionnaire (inability to read French, severe cognitive impairment);
- Subject to which the scheduled surgery may cause postoperative cognitive dysfunction (intracranial surgery, extracorporeal circulation);
- Topic scheduled for obstetrical surgery or outpatient;
- Subject treated with antipsychotic (neuroleptic or lithium);
- Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
- Subject active consumer of narcotics;
- Subject has not signed informed consent.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01901003
Start Date
November 1 2012
End Date
June 1 2014
Last Update
April 21 2015
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354