NCT01901003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

July 10, 2013

Last Update Submit

April 20, 2015

Conditions

Perioperative Anxiety

Outcome Measures

Primary Outcomes (1)

  • the EVAN score

    to evaluate patient satisfaction of the perioperative period

    2 years

Secondary Outcomes (1)

  • the perioperative level of anxiety

    2 years

Study Arms (3)

placebo group

PLACEBO COMPARATOR

placebo

Drug: Placebo (microcrystalline celluloses)

no premedication group

ACTIVE COMPARATOR

no premedication

Other: no premedication

Lorazepam group

EXPERIMENTAL

lorazepam

Drug: Lorazepam

Interventions

LorazepamDRUG
Lorazepam group
no premedicationOTHER
no premedication group
Placebo (microcrystalline celluloses)DRUG
placebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Having no cons-indication to the use of benzodiazepines;
  • Having no known allergy to benzodiazepines;
  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • 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.

    PMID: 25734733DERIVED

MeSH Terms

Interventions

Lorazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • LOIC MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 17, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

FR(1)