NCT02213302

Premedication by Midazolam for Emergency Surgery

Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety

Interventions

Type	Name	Description
DRUG	placebo administration
DRUG	midazolam intravenous administration

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-08-11
• Last updated: 2016-02-11

Locations

1 site across 1 country: France