Premedication by Midazolam for Emergency Surgery

University Hospital, Lille59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anxiety

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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