CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
placebo administration +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02213302
NCT02213302Phase 4Completed

Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery

University Hospital, Lille·interventional·Posted Aug 11, 2014·Updated Feb 11, 2016

In Brief

A Phase 4 clinical trial evaluating placebo administration and midazolam intravenous administration for Anxiety. Completed, enrolled 59 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 11, 2014
Enrollment StartJul 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.9 years ago

Interventions

placebo administrationdrug

midazolam intravenous administrationdrug