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Premedication by Midazolam for Emergency Surgery

NCT02213302 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-02-11

No results posted yet for this study

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

Interventions

DRUG

placebo administration

DRUG

midazolam intravenous administration

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Elise Blondé-Zoonekynd, Physician · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02213302 on ClinicalTrials.gov