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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

Tracking Information
First Submitted Date  ICMJE July 10, 2013
First Posted Date  ICMJE July 17, 2013
Last Update Posted Date April 21, 2015
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
the EVAN score [ Time Frame: 2 years ]
to evaluate patient satisfaction of the perioperative period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01901003 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
the perioperative level of anxiety [ Time Frame: 2 years ]
APAIS score (Moerman 1996) before surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sedative Premedication: Efficacy On Patient Experience
Official Title  ICMJE SEDATIVE PREMEDICATION: EFFICACY ON PATIENT EXPERIENCE
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Perioperative Anxiety
Intervention  ICMJE
  • Drug: Lorazepam
  • Other: no premedication
  • Drug: Placebo (microcrystalline celluloses)
Study Arms  ICMJE
  • Placebo Comparator: placebo group
    placebo
    Intervention: Drug: Placebo (microcrystalline celluloses)
  • Active Comparator: no premedication group
    no premedication
    Intervention: Other: no premedication
  • Experimental: Lorazepam group
    lorazepam
    Intervention: Drug: Lorazepam
Publications * Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2013)
1200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01901003
Other Study ID Numbers  ICMJE 2011-005171-16
2011-32 ( Other Identifier: AP HM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP