Premedication by Midazolam for Emergency Surgery

NCT02213302 | Completed Phase 4 DMC

• 2 other identifiers: 2014-000873-38PROM 2012_30
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

premedication; preoperative anxiety; salivary cortisol level; anxiety visual analog scale

Outcome Measures

Primary Outcomes (1)

• visual analog scale of anxiety

  visual scale rated from 0 to 10 to describe the intensity of anxiety simple and reproducible measurement for a short period

  baseline, up to the end of support in recovery room

Secondary Outcomes (8)

• salivary cortisol level

  baseline and at the entrance in operating room

• Global anxiety

  baseline

• Patient's satisfaction

  at the end of the support in recovery room

• Intraoperative consumption of hypnotics and opioids

  at anesthesia induction up to 10 minutes

• Comfort induction

  at anesthesia induction

Study Arms (2)

Isotonic serum

PLACEBO COMPARATOR

placebo administration

Drug: placebo administration; Drug: midazolam intravenous administration

Midazolam

ACTIVE COMPARATOR

midazolam intravenous administration 0.02mg/kg

Drug: placebo administration; Drug: midazolam intravenous administration

Interventions

placebo administration DRUG

Also known as: isotonic saline serum intravenous administration

Isotonic serum; Midazolam

midazolam intravenous administration DRUG

Also known as: hypnovel

Isotonic serum; Midazolam

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Emergency, University Hopital

Lille, 59000, France

Location

Related Publications (8)

• 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.

  PMID: 18772216 RESULT

• 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.

  PMID: 2457102 RESULT

• 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.

  PMID: 15217656 RESULT

• 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.

  PMID: 16243241 RESULT

• 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.

  PMID: 21602018 RESULT

• 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.

  PMID: 8623940 RESULT

• Reves JG, Fragen RJ, Vinik HR, Greenblatt DJ. Midazolam: pharmacology and uses. Anesthesiology. 1985 Mar;62(3):310-24.

  PMID: 3156545 RESULT

• 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.

  PMID: 20224951 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Elise Blondé-Zoonekynd, Physician

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: August 11, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 11, 2016

Record last verified: 2016-02

Locations

FR (1)