A Phase 4 interventional study of placebo administration and midazolam intravenous administration in Anxiety, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-02-11.
Sponsored by University Hospital, Lille · Phase 4, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 59 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
placebo administration
Drug: placebo administration · Drug: midazolam intravenous administration
midazolam intravenous administration 0.02mg/kg
Drug: placebo administration · Drug: midazolam intravenous administration
Also known as: isotonic saline serum intravenous administration
Also known as: hypnovel
visual analog scale of anxiety
visual scale rated from 0 to 10 to describe the intensity of anxiety simple and reproducible measurement for a short period
Time frame: baseline, up to the end of support in recovery room
salivary cortisol level
biologic measurement non-invasive, inexpensive and easy to perform. two determinations before and after premedication (at least 20 minutes)
Time frame: baseline and at the entrance in operating room
Global anxiety
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
Time frame: baseline
Patient's satisfaction
rated from 1 for bad management to 5 for excellent management assessed at the output of the recovery room
Time frame: at the end of the support in recovery room
Intraoperative consumption of hypnotics and opioids
Cumulative dose of hypnotics and opioids reduced to dose per kilogram
Time frame: at anesthesia induction up to 10 minutes
Comfort induction
rated from 1 for deep discomfort to 5 for good comfort
Time frame: at anesthesia induction
Intubation score
Rated from 1 bed conditions for intubation to 5 for excellent conditions
Time frame: after intubation
Adverse midazolam effects
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
Time frame: baseline up to the end of support in recovery room
Output score of recovery room (Aldrete score)
rated from 0 to 10 essential for the output of recovery room
Time frame: at the end of support in recovery room
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille