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Premedication by Midazolam for Emergency Surgery

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ClinicalTrials.gov Identifier: NCT02213302
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
Preoperative anxiety is a subjective and painful experience and may have adverse psychological consequences and complicate anesthetic management. The aim of the study is to show the effect of premedication by midazolam on preoperative anxiety assessed by a visual analog scale and by measuring salivary cortisol levels. This study was a monocentric, prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to 79 years, to undergo elective surgery under general anesthesia with tracheal intubation must be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of respiratory and hemodynamic adverse effects of midazolam.

Condition or disease Intervention/treatment Phase
Anxiety Drug: placebo administration Drug: midazolam intravenous administration Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery
Study Start Date : July 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Placebo Comparator: Isotonic serum
placebo administration
Drug: placebo administration
Other Name: isotonic saline serum intravenous administration

Drug: midazolam intravenous administration
Other Name: hypnovel

Active Comparator: Midazolam
midazolam intravenous administration 0.02mg/kg
Drug: placebo administration
Other Name: isotonic saline serum intravenous administration

Drug: midazolam intravenous administration
Other Name: hypnovel




Primary Outcome Measures :
  1. visual analog scale of anxiety [ Time Frame: baseline, up to the end of support in recovery room ]
    visual scale rated from 0 to 10 to describe the intensity of anxiety simple and reproducible measurement for a short period


Secondary Outcome Measures :
  1. salivary cortisol level [ Time Frame: baseline and at the entrance in operating room ]
    biologic measurement non-invasive, inexpensive and easy to perform. two determinations before and after premedication (at least 20 minutes)

  2. Global anxiety [ Time Frame: baseline ]
    rated from 4 to 20 for global anxiety and from 2 to 10 for information request anxiety is high above 10 for women and 12 for men

  3. Patient's satisfaction [ Time Frame: at the end of the support in recovery room ]
    rated from 1 for bad management to 5 for excellent management assessed at the output of the recovery room

  4. Intraoperative consumption of hypnotics and opioids [ Time Frame: at anesthesia induction up to 10 minutes ]
    Cumulative dose of hypnotics and opioids reduced to dose per kilogram

  5. Comfort induction [ Time Frame: at anesthesia induction ]
    rated from 1 for deep discomfort to 5 for good comfort

  6. Intubation score [ Time Frame: after intubation ]
    Rated from 1 bed conditions for intubation to 5 for excellent conditions

  7. Adverse midazolam effects [ Time Frame: baseline up to the end of support in recovery room ]
    assessed by variations of arterial pressure, heart rate, respiratory rate, oxygen saturation and end tidal of carbon dioxide for hemodynamics and respiratory adverse effects assessed by Observer's assessment of alertness/sedation for deep of sedation rated from 1 sleeping patient to 5 for awake patient

  8. Output score of recovery room (Aldrete score) [ Time Frame: at the end of support in recovery room ]
    rated from 0 to 10 essential for the output of recovery room



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • major patient undergoing elective surgery under general anesthesia with tracheal intubation
  • Anesthesia state 1 and 2
  • preoperative fasting for 6 hours
  • information and signed consent
  • social security
  • non pregnant women

Exclusion Criteria:

  • anesthesia state above 3
  • midazolam sensibility
  • pregnant or breastfeeding women
  • ICU patients
  • no consent
  • pediatric surgery
  • no social security
  • no tracheal intubation
  • required premedication in placebo group or midazolam sensibility in premedication group

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213302


Locations
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France
Emergency, University Hopital
Lille, France, 59000
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Elise Blondé-Zoonekynd, Physician University Hospital, Lille

Publications of Results:

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02213302     History of Changes
Other Study ID Numbers: 2014-000873-38
PROM 2012_30 ( Other Identifier: University hospital, Lille )
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by University Hospital, Lille:
premedication
preoperative anxiety
salivary cortisol level
anxiety visual analog scale
Additional relevant MeSH terms:
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Emergencies
Anxiety Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action