Reassessment of Premedication in Surgery

Overview

The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients. – one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery – one receiving zopiclone (7.5 mg) before sleep and placebo at awakening – one receiving placebo before sleep and alprazolam (0.5 mg)at awakening double blind, randomized controlled study

Full Title of Study: “Assessment of Two Modes of Premedication in Surgery – PREMED Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2013

Detailed Description

Eligibility: – 18 to 65 years old – elective surgery – in-hospital preoperative night Outcome measures: – anxiety scales – demographic data

Interventions

  • Drug: Zopiclone
    • 7.5 mg before sleep, the evening before surgery
  • Drug: Alprazolam
    • 0.5 mg at awakening, the day of surgery
  • Drug: placebo
    • given night before surgery and at awakening, the day of surgery

Arms, Groups and Cohorts

  • Experimental: zopiclone
    • zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)
  • Experimental: alprazolam
    • given at awakening, the day of surgery (placebo given before sleep, the day before surgery)
  • Placebo Comparator: placebo
    • Placebo given night before operation and the morning of operation

Clinical Trial Outcome Measures

Primary Measures

  • anxiety scales
    • Time Frame: duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating room)
    • * The day before surgery (late afternoon) : patient’s self rating of anxiety and desire of information regarding upcoming surgery (Amsterdam patient anxiety and information scale, APAIS) * On arrival to the operating room : Recording of the level of declared anxiety (numeric scale similar to that corresponding of the “anxiety component of the APAIS scale)

Secondary Measures

  • markers of stress
    • Time Frame: on arrival to operating room (one single recording)
    • recording of actual (using the operating room monitor): heart rate (at rest, supine) systolic blood pressure (at rest, supine)

Participating in This Clinical Trial

Inclusion Criteria

  • age 18-65 years old – elective surgery – in-hospital night before surgery Exclusion Criteria:

  • myasthenia gravis – chronic intake of psychotropic drugs – opiates intake – severe obstructive sleep apnea – intracranial hypertension – morbid obesity – myasthenia gravis – acute severe medical disorder – non health insurance coverage – protected patients by law – pregnancy – non French speaking

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Angers
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Laurent Beydon, MD, Study Chair, University Hospital Angers (Dept of Anesthesia)

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