AnxietyPhase 4PREMEDNCT01549691
Reassessment of Premedication in Surgery
A Phase 4 study testing Zopiclone and Alprazolam in people with Anxiety, run by University Hospital, Angers at 8 sites in France.
Trial summary
The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients. one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Zopiclone and Alprazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 8 sitesFrance
- Study dates
- Mar 2012to Apr 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years old
- elective surgery
- in-hospital night before surgery
Who cannot join
- myasthenia gravis
- chronic intake of psychotropic drugs
- opiates intake
- severe obstructive sleep apnea
- intracranial hypertension
- morbid obesity
Show all 12Show fewer
- myasthenia gravis
- acute severe medical disorder
- non health insurance coverage
- protected patients by law
- pregnancy
- non French speaking
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Paul Papin
Angers, Maine et Loire, 49000
University Hospital
Angers, Maine et Loire, 49933
Clinique Sévigné
Cesson, Brittany Region, 35576
Dept of Anesthesia
Le Mans, Maine, 72000
Dept of Anesthesia, Hôpital Tenon
Paris, Île-de-France Region, 75020
Dept of Anesthesia, Hôpital Maison Blanche
Reims, Champagne, 51092
Dept of Anesthesia, Hôpital Foch,
Suresnes, Île-de-France Region, 92150
Clinique St Leonard
Trélazé, Maine et Loire, 49800
About this study
Official title: Assessment of Two Modes of Premedication in Surgery - PREMED Study
The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.
- one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery
- one receiving zopiclone (7.5 mg) before sleep and placebo at awakening
- one receiving placebo before sleep and alprazolam (0.5 mg)at awakening double blind, randomized controlled study
Read the detailed description
Eligibility:
- 18 to 65 years old
- elective surgery
- in-hospital preoperative night
Outcome measures:
- anxiety scales
- demographic data
- Conditions
- Anxiety
- Being tested
- Zopiclone, Alprazolam, placebo
- Keywords
- Premedication, Benzodiazepine, Anti-anxiety agents, Anxiety, Surgery, Adult, Human
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZopicloneDrug
Also called Imovane
7.5 mg before sleep, the evening before surgery
AlprazolamDrug
Also called Xanax
0.5 mg at awakening, the day of surgery
placeboDrug
given night before surgery and at awakening, the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| zopiclone | Experimental | zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery) Receives: Drug: Zopiclone |
| alprazolam | Experimental | given at awakening, the day of surgery (placebo given before sleep, the day before surgery) Receives: Drug: Alprazolam |
| placebo | Placebo comparator | Placebo given night before operation and the morning of operation Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety scales
- The day before surgery (late afternoon) : patient's self rating of anxiety and desire of information regarding upcoming surgery (Amsterdam patient anxiety and information scale, APAIS)
- On arrival to the operating room : Recording of the level of declared anxiety (numeric scale similar to that corresponding of the "anxiety component of the APAIS scale)
Measured: duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating room)
Secondary outcomes (1)
markers of stress
recording of actual (using the operating room monitor):
- heart rate (at rest, supine)
- systolic blood pressure (at rest, supine)
Measured: on arrival to operating room (one single recording)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 455 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laurent Beydon, MD, Study chair, University Hospital Angers (Dept of Anesthesia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549691
- Sponsor's protocol ID
- PHRC 2011-20
- Other IDs
- 2011-002553-65
- Acronym
- PREMED
- Status last verified
- Sep 2013
- First submitted
- 23 Feb 2012
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beydon L, Rouxel A, Camut N, Schinkel N, Malinovsky JM, Aveline C, Marret E, Bildea A, Dupoiron D, Liu N, Daniel V, Darsonval A, Chretien JM, Rault L, Bruna J, Alberti C. Sedative premedication before surgery--A multicentre randomized study versus placebo. Anaesth Crit Care Pain Med. 2015 Jun;34(3):165-71. doi: 10.1016/j.accpm.2015.01.005. Epub 2015 May 23.
PubMed 26004882
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Two Modes of Premedication in Surgery - PREMED Study
- ClinicalTrials.gov ID
- NCT01549691
- Acronym / sponsor ID
- PREMED / PHRC 2011-20
- Conditions
- Anxiety
- Keywords
- Premedication, Benzodiazepine, Anti-anxiety agents, Anxiety, Surgery, Adult, Human
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.
- one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery
- one receiving zopiclone (7.5 mg) before sleep and placebo at awakening
- one receiving placebo before sleep and alprazolam (0.5 mg)at awakening double blind, randomized controlled study
Detailed description
Eligibility:
- 18 to 65 years old
- elective surgery
- in-hospital preoperative night
Outcome measures:
- anxiety scales
- demographic data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zopiclone | Experimental | Drug: Zopiclonezopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery) |
| alprazolam | Experimental | Drug: Alprazolamgiven at awakening, the day of surgery (placebo given before sleep, the day before surgery) |
| placebo | Placebo comparator | Drug: placeboPlacebo given night before operation and the morning of operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-65 years old
- elective surgery
- in-hospital night before surgery
Key exclusion criteria (12 listed)
- myasthenia gravis
- chronic intake of psychotropic drugs
- opiates intake
- severe obstructive sleep apnea
- intracranial hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZopicloneAlso: Imovane7.5 mg before sleep, the evening before surgery | Drug | zopiclone |
| AlprazolamAlso: Xanax0.5 mg at awakening, the day of surgery | Drug | alprazolam |
| placebogiven night before surgery and at awakening, the day of surgery | Drug | placebo |
Primary outcome
anxiety scales
Time frame: duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating room)
* The day before surgery (late afternoon) : patient's self rating of anxiety and desire of information regarding upcoming surgery (Amsterdam patient anxiety and information scale, APAIS) * On arrival to the operating room : Recording of the level of declared anxiety (numeric scale similar to that corresponding of the "anxiety component of the APAIS scale)
1 secondary outcome
markers of stress
Time frame: on arrival to operating room (one single recording)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
- Derived from this study: PubMed 26004882Beydon L, Rouxel A, Camut N, Schinkel N, Malinovsky JM, Aveline C, Marret E, Bildea A, Dupoiron D, Liu N, Daniel V, Darsonval A, Chretien JM, Rault L, Bruna J, Alberti C. Sedative premedication before surgery--A multicentre randomized study versus placebo. Anaesth Crit Care Pain Med. 2015 Jun;34(3):165-71. doi: 10.1016/j.accpm.2015.01.005. Epub 2015 May 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Beydon, MD study chair
University Hospital Angers (Dept of Anesthesia)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zopiclone and Alprazolam in people with Anxiety, run by University Hospital, Angers at 8 sites 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 3 inclusion and 12 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 25 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
anxiety scales (time frame: duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating 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 NCT01549691, which also lists 1 linked publication.
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 25 Sep 2013.