Premedication by Midazolam for Emergency Surgery
- Conditions
- Anxiety
- Interventions
- Drug: placebo administration
- Registration Number
- NCT02213302
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Isotonic serum placebo administration placebo administration Isotonic serum midazolam intravenous administration placebo administration Midazolam placebo administration midazolam intravenous administration 0.02mg/kg Midazolam midazolam intravenous administration midazolam intravenous administration 0.02mg/kg
- Primary Outcome Measures
Name Time Method visual analog scale of anxiety 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
Name Time Method Global anxiety 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
Intraoperative consumption of hypnotics and opioids at anesthesia induction up to 10 minutes Cumulative dose of hypnotics and opioids reduced to dose per kilogram
Intubation score after intubation Rated from 1 bed conditions for intubation to 5 for excellent conditions
Adverse midazolam effects 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
Patient's satisfaction 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
Comfort induction at anesthesia induction rated from 1 for deep discomfort to 5 for good comfort
Output score of recovery room (Aldrete score) at the end of support in recovery room rated from 0 to 10 essential for the output of recovery room
salivary cortisol level 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)
Trial Locations
- Locations (1)
Emergency, University Hopital
🇫🇷Lille, France