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Completed

NCT Number: NCT02213302

Premedication by Midazolam for Emergency Surgery

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emergency, University Hopital

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Administration

Drug

Other names: isotonic saline serum intravenous administration

midazolam intravenous administration

Drug

Other names: hypnovel

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2014
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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