Sedative Premedication: Efficacy On Patient Experience

Perioperative Anxiety Clinical Trial

— PremedX  

Official title:

SEDATIVE PREMEDICATION: EFFICACY ON PATIENT EXPERIENCE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901003
• Other study ID #: 2011-005171-16
• Secondary ID: 2011-32
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2013
• Last updated: April 20, 2015
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perioperative Anxiety

Intervention

Drug:
• Lorazepam

Other:
• no premedication

Drug:
• Placebo (microcrystalline celluloses)

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the EVAN score	to evaluate patient satisfaction of the perioperative period	2 years	No
Secondary	the perioperative level of anxiety	APAIS score (Moerman 1996) before surgery	2 years	No