Recruitment

Recruitment Status
Completed

Inclusion Criterias

male or female aged 18 to 70 years or more;
Having no known allergy to benzodiazepines;
May be a candidate for the prescription of premedication;
...
male or female aged 18 to 70 years or more;
Having no known allergy to benzodiazepines;
May be a candidate for the prescription of premedication;
Having no cons-indication to the use of benzodiazepines;
About a weight greater than 45 kg;
Topic able to complete a self-administered questionnaire;
Subject to benefit from a scheduled surgery under general anesthesia;
Subject has signed a written informed consent and agreeing to abide by the instructions of the Protocol

Exclusion Criterias

Topic demanding to receive anxiolytic premedication;
Topic minor, pregnant or breastfeeding, about not being affiliated to the social security system;
Topic 45 kg or less;
...
Topic demanding to receive anxiolytic premedication;
Topic minor, pregnant or breastfeeding, about not being affiliated to the social security system;
Topic 45 kg or less;
Topic for which surgery is performed under local anesthesia;
Subject severe respiratory insufficiency;
Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
Subject unable to perform only a self-administered questionnaire (inability to read French, severe cognitive impairment);
Topic scheduled for obstetrical surgery or outpatient;
Subject to which the scheduled surgery may cause postoperative cognitive dysfunction (intracranial surgery, extracorporeal circulation);
Subject active consumer of narcotics;
- Topic of over 70 years;
Subject treated with antipsychotic (neuroleptic or lithium);
Subject has not signed informed consent.

Summary

Conditions
Perioperative Anxiety
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Inclusion Criterias

male or female aged 18 to 70 years or more;
Having no known allergy to benzodiazepines;
May be a candidate for the prescription of premedication;
...
male or female aged 18 to 70 years or more;
Having no known allergy to benzodiazepines;
May be a candidate for the prescription of premedication;
Having no cons-indication to the use of benzodiazepines;
About a weight greater than 45 kg;
Topic able to complete a self-administered questionnaire;
Subject to benefit from a scheduled surgery under general anesthesia;
Subject has signed a written informed consent and agreeing to abide by the instructions of the Protocol

Exclusion Criterias

Topic demanding to receive anxiolytic premedication;
Topic minor, pregnant or breastfeeding, about not being affiliated to the social security system;
Topic 45 kg or less;
...
Topic demanding to receive anxiolytic premedication;
Topic minor, pregnant or breastfeeding, about not being affiliated to the social security system;
Topic 45 kg or less;
Topic for which surgery is performed under local anesthesia;
Subject severe respiratory insufficiency;
Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
Subject unable to perform only a self-administered questionnaire (inability to read French, severe cognitive impairment);
Topic scheduled for obstetrical surgery or outpatient;
Subject to which the scheduled surgery may cause postoperative cognitive dysfunction (intracranial surgery, extracorporeal circulation);
Subject active consumer of narcotics;
- Topic of over 70 years;
Subject treated with antipsychotic (neuroleptic or lithium);
Subject has not signed informed consent.

Locations

Marseille, 13354
Marseille, 13354

Tracking Information

NCT #
NCT01901003
Collaborators
Not Provided
Investigators
Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille