Premedication by Midazolam for Emergency Surgery

University Hospital, Lille

Status and phase: Completed; Phase 4

Conditions: Anxiety

Treatments: Drug: placebo administration; Drug: midazolam intravenous administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02213302

2014-000873-38

PROM 2012_30 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

Isotonic serum

Placebo Comparator group

Description:

placebo administration

Treatment:

Drug: midazolam intravenous administration

Drug: placebo administration

Midazolam

Active Comparator group

Description:

midazolam intravenous administration 0.02mg/kg

Treatment:

Drug: midazolam intravenous administration

Drug: placebo administration