Sedative Premedication: Efficacy On Patient Experience
Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Perioperative Anxiety
Intervention: Lorazepam (Drug); no premedication (Other); Placebo (microcrystalline celluloses) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Assistance Publique Hopitaux De Marseille Official(s) and/or principal investigator(s): LOIC MONDOLONI, Study Director, Affiliation: Assistance Publique Hopitaux De Marseille
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 celluloses) and no premedication at all. The third group (no
premedication) is necessary in order to evaluate a placebo response, which may be
significant on anxiety level and patients perceptions of care. It was calculated that 969
patients had to be included in order to obtain a 5 point difference between groups on the
EVAN score with 80 % statistical power, leading to the inclusion of 1200 patients with an
estimated maximum dropout rate of 15 %. All adults below 70 years and scheduled for elective
surgery under general anesthesia can be included after information by an anesthesiologist in
charge of the study and written informed consent. Non inclusion criterions are: a weight
below 45 Kg, a counter indication to benzodiazepine, surgeries that could impair cognitive
functions (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug
addiction or former cognitive disease. The technique of anesthesia will be decided by the
attending anesthesiologist, who will be unaware of the premedication technique,
independently of the study protocol.
Clinical Details
Official title: SEDATIVE PREMEDICATION: EFFICACY ON PATIENT EXPERIENCE
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: the EVAN score
Secondary outcome: the perioperative level of anxiety
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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:
1. Having no cons-indication to the use of benzodiazepines;
2. Having no known allergy to benzodiazepines;
3. 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 Criteria:
- - 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.
Locations and Contacts
Assistance Publique Hopitaux de Marseille, Marseille 13354, France
Additional Information
Starting date: November 2012
Last updated: April 20, 2015
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