Premedication by Midazolam for Emergency Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery

Conditions
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Anxiety

Intervention / Treatment
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* Drug: placebo administration
* Drug: midazolam intravenous administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Isotonic serum<br>placebo administration | Drug: placebo administration<br> <br> * Other names: isotonic saline serum intravenous administration;Drug: midazolam intravenous administration<br> <br> * Other names: hypnovel;|
| Active Comparator: Midazolam<br>midazolam intravenous administration 0.02mg/kg | Drug: placebo administration<br> <br> * Other names: isotonic saline serum intravenous administration;Drug: midazolam intravenous administration<br> <br> * Other names: hypnovel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, up to the end of support in recovery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary cortisol level | biologic measurement non-invasive, inexpensive and easy to perform. two determinations before and after premedication (at least 20 minutes) | 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 | baseline | 
| Patient's satisfaction | rated from 1 for bad management to 5 for excellent management assessed at the output of the recovery room | 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 | at anesthesia induction up to 10 minutes | 
| Comfort induction | rated from 1 for deep discomfort to 5 for good comfort | at anesthesia induction | 
| Intubation score | Rated from 1 bed conditions for intubation to 5 for excellent conditions | 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 | 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 | at the end of support in recovery room | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premedication, preoperative anxiety, salivary cortisol level, anxiety visual analog scale