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Sedative Premedication: Efficacy On Patient Experience (PremedX)

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ClinicalTrials.gov Identifier: NCT01901003
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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 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.

Condition or disease Intervention/treatment Phase
Perioperative Anxiety Drug: Lorazepam Other: no premedication Drug: Placebo (microcrystalline celluloses) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: SEDATIVE PREMEDICATION: EFFICACY ON PATIENT EXPERIENCE
Study Start Date : November 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Lorazepam

Arm Intervention/treatment
Placebo Comparator: placebo group
placebo
Drug: Placebo (microcrystalline celluloses)
Active Comparator: no premedication group
no premedication
Other: no premedication
Experimental: Lorazepam group
lorazepam
Drug: Lorazepam



Primary Outcome Measures :
  1. the EVAN score [ Time Frame: 2 years ]
    to evaluate patient satisfaction of the perioperative period


Secondary Outcome Measures :
  1. the perioperative level of anxiety [ Time Frame: 2 years ]
    APAIS score (Moerman 1996) before surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901003


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01901003     History of Changes
Other Study ID Numbers: 2011-005171-16
2011-32 ( Other Identifier: AP HM )
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Lorazepam
Hypnotics and Sedatives
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action