Premedication by Midazolam for Emergency Surgery

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Treatments: Midazolam

Criteria

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