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AnxietyPhase 4NCT02213302

Premedication by Midazolam for Emergency Surgery

A Phase 4 study testing midazolam intravenous administration in people with Anxiety, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Anxiety
What is being tested?
midazolam intravenous administration
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
1 siteFrance
Study dates
Jul 2014to Jan 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • anesthesia state above 3
  • midazolam sensibility
  • pregnant or breastfeeding women
  • ICU patients
  • no consent
  • pediatric surgery
Show all 9Show fewer
  • no social security
  • no tracheal intubation
  • required premedication in placebo group or midazolam sensibility in premedication group

Trial locations and contacts

1 site in 1 country.

France1 site

  • Emergency, University Hopital

    Lille, 59000

Other trials in France

About this study

Official title: Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery

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
Being tested
placebo administration, midazolam intravenous administration
Keywords
premedication, preoperative anxiety, salivary cortisol level, anxiety visual analog scale
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placebo administrationDrug

    Also called isotonic saline serum intravenous administration

  • midazolam intravenous administrationDrug

    Also called hypnovel

Study groups in NCT02213302
Study groupRoleWhat they receive
Isotonic serumPlacebo comparatorplacebo administration
Receives: Drug: placebo administration; Drug: midazolam intravenous administration
MidazolamActive comparatormidazolam intravenous administration 0.02mg/kg
Receives: Drug: placebo administration; Drug: midazolam intravenous administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, up to the end of support in recovery room

Secondary outcomes (8)

  1. salivary cortisol level

    biologic measurement non-invasive, inexpensive and easy to perform. two determinations before and after premedication (at least 20 minutes)

    Measured: baseline and at the entrance in operating room

  2. Global anxiety

    rated from 4 to 20 for global anxiety and from 2 to 10 for information request anxiety is high above 10 for women and 12 for men

    Measured: baseline

  3. Patient's satisfaction

    rated from 1 for bad management to 5 for excellent management assessed at the output of the recovery room

    Measured: at the end of the support in recovery room

  4. Intraoperative consumption of hypnotics and opioids

    Cumulative dose of hypnotics and opioids reduced to dose per kilogram

    Measured: at anesthesia induction up to 10 minutes

  5. Comfort induction

    rated from 1 for deep discomfort to 5 for good comfort

    Measured: at anesthesia induction

  6. Intubation score

    Rated from 1 bed conditions for intubation to 5 for excellent conditions

    Measured: after intubation

  7. Adverse midazolam effects

    assessed by variations of arterial pressure, heart rate, respiratory rate, oxygen saturation and end tidal of carbon dioxide for hemodynamics and respiratory adverse effects assessed by Observer's assessment of alertness/sedation for deep of sedation rated from 1 sleeping patient to 5 for awake patient

    Measured: baseline up to the end of support in recovery room

  8. Output score of recovery room (Aldrete score)

    rated from 0 to 10 essential for the output of recovery room

    Measured: at the end of support in recovery room

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213302
Sponsor's protocol ID
2014-000873-38
Other IDs
PROM 2012_30, 2014
Status last verified
Feb 2016
First submitted
2 Jul 2014
Last updated
11 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18772216

  • 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.

    PubMed 2457102

  • 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.

    PubMed 15217656

  • 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.

    PubMed 16243241

  • 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.

    PubMed 21602018

  • 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.

    PubMed 8623940

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

    PubMed 3156545

  • 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.

    PubMed 20224951

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing midazolam intravenous administration in people with Anxiety, run by University Hospital, Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

visual analog scale of anxiety (time frame: baseline, up to the end of support in recovery room). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02213302, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.

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