Clinical trial NCT02213302: Premedication by Midazolam for Emergency Surgery
Official title: Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety
Keywords: premedication
preoperative anxiety
salivary cortisol level
anxiety visual analog scale
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: visual analog scale of anxiety
timeFrame: baseline, up to the end of support in recovery room
Secondary outcomes:
measure: salivary cortisol level
timeFrame: baseline and at the entrance in operating room
measure: Global anxiety
timeFrame: baseline
measure: Patient's satisfaction
timeFrame: at the end of the support in recovery room
measure: Intraoperative consumption of hypnotics and opioids
timeFrame: at anesthesia induction up to 10 minutes
measure: Comfort induction
timeFrame: at anesthesia induction
measure: Intubation score
timeFrame: after intubation
measure: Adverse midazolam effects
timeFrame: baseline up to the end of support in recovery room
measure: Output score of recovery room (Aldrete score)
timeFrame: at the end of support in recovery room
Other outcomes:
Locations:
city: Lille
country: France
facility: Emergency, University Hopital
Study officials:
affiliation: University Hospital, Lille
name: Elise Blondé-Zoonekynd, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun GC, Hsu MC, Chia YY, Chen PY, Shaw FZ. Effects of age and gender on intravenous midazolam premedication: a randomized double-blind study. Br J Anaesth. 2008 Nov;101(5):632-9. doi: 10.1093/bja/aen251. Epub 2008 Sep 4.
citation: Vogelsang J. The Visual Analog Scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs. 1988 Aug;3(4):235-9. No abstract available.
citation: Bauer KP, Dom PM, Ramirez AM, O'Flaherty JE. Preoperative intravenous midazolam: benefits beyond anxiolysis. J Clin Anesth. 2004 May;16(3):177-83. doi: 10.1016/j.jclinane.2003.07.003.
citation: Jerjes W, Jerjes WK, Swinson B, Kumar S, Leeson R, Wood PJ, Kattan M, Hopper C. Midazolam in the reduction of surgical stress: a randomized clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):564-70. doi: 10.1016/j.tripleo.2005.02.087.
citation: Wattier JM, Barreau O, Devos P, Prevost S, Vallet B, Lebuffe G. [Measure of preoperative anxiety and need for information with six issues]. Ann Fr Anesth Reanim. 2011 Jul-Aug;30(7-8):533-7. doi: 10.1016/j.annfar.2011.03.010. Epub 2011 May 23. French.
citation: Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
citation: Reves JG, Fragen RJ, Vinik HR, Greenblatt DJ. Midazolam: pharmacology and uses. Anesthesiology. 1985 Mar;62(3):310-24.
citation: Zalunardo MP, Ivleva-Sauerborn A, Seifert B, Spahn DR. [Quality of premedication and patient satisfaction after premedication with midazolam, clonidine or placebo : Randomized double-blind study with age-adjusted dosage]. Anaesthesist. 2010 May;59(5):410-8. doi: 10.1007/s00101-010-1695-9. German.