Perioperative AnxietyPhase 3PremedXNCT01901003
Sedative Premedication: Efficacy On Patient Experience
A Phase 3 study testing Lorazepam and no premedication in people with Perioperative Anxiety, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Seven French university hospitals will participate in this multicentric prospective, blinded and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo (microcrystalline celluloses) and no premedication at all. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perioperative Anxiety
- What is being tested?
- Lorazepam and no premedication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Jun 2014
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female aged 18 to 70 years or more;
- About a weight greater than 45 kg;
- Subject to benefit from a scheduled surgery under general anesthesia;
- Topic respecting the ambivalence clause defined below:
- Having no cons-indication to the use of benzodiazepines;
- Having no known allergy to benzodiazepines;
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- May be a candidate for the prescription of premedication;
- Topic able to complete a self-administered questionnaire;
- Subject has signed a written informed consent and agreeing to abide by the instructions of the Protocol
Who cannot join
- - Topic of over 70 years;
- Topic 45 kg or less;
- Topic demanding to receive anxiolytic premedication;
- Subject severe respiratory insufficiency;
- Topic minor, pregnant or breastfeeding, about not being affiliated to the social security system;
- Topic for which surgery is performed under local anesthesia;
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- Subject unable to perform only a self-administered questionnaire (inability to read French, severe cognitive impairment);
- Subject to which the scheduled surgery may cause postoperative cognitive dysfunction (intracranial surgery, extracorporeal circulation);
- Topic scheduled for obstetrical surgery or outpatient;
- Subject treated with antipsychotic (neuroleptic or lithium);
- Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
- Subject active consumer of narcotics;
- Subject has not signed informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SEDATIVE PREMEDICATION: EFFICACY ON PATIENT EXPERIENCE
Seven French university hospitals will participate in this multicentric prospective, blinded and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo (microcrystalline celluloses) and no premedication at all. The third group (no premedication) is necessary in order to evaluate a placebo response, which may be significant on anxiety level and patients perceptions of care. It was calculated that 969 patients had to be included in order to obtain a 5 point difference between groups on the EVAN score with 80 % statistical power, leading to the inclusion of 1200 patients with an estimated maximum dropout rate of 15 %. All adults below 70 years and scheduled for elective surgery under general anesthesia can be included after information by an anesthesiologist in charge of the study and written informed consent. Non inclusion criterions are: a weight below 45 Kg, a counter indication to benzodiazepine, surgeries that could impair cognitive functions (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug addiction or former cognitive disease. The technique of anesthesia will be decided by the attending anesthesiologist, who will be unaware of the premedication technique, independently of the study protocol.
- Conditions
- Perioperative Anxiety
- Being tested
- Lorazepam, no premedication, Placebo (microcrystalline celluloses)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
no premedicationOther
Placebo (microcrystalline celluloses)Drug
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | placebo Receives: Drug: Placebo (microcrystalline celluloses) |
| no premedication group | Active comparator | no premedication Receives: Other: no premedication |
| Lorazepam group | Experimental | lorazepam Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
the EVAN score
to evaluate patient satisfaction of the perioperative period
Measured: 2 years
Secondary outcomes (1)
the perioperative level of anxiety
APAIS score (Moerman 1996) before surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
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 Perioperative AnxietyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901003
- Sponsor's protocol ID
- 2011-005171-16
- Other IDs
- 2011-32
- Acronym
- PremedX
- Status last verified
- Apr 2015
- First submitted
- 10 Jul 2013
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.
PubMed 25734733
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEDATIVE PREMEDICATION: EFFICACY ON PATIENT EXPERIENCE
- ClinicalTrials.gov ID
- NCT01901003
- Acronym / sponsor ID
- PremedX / 2011-005171-16
- Conditions
- Perioperative Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Jul 2013 (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.
Seven French university hospitals will participate in this multicentric prospective, blinded and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo (microcrystalline celluloses) and no premedication at all. The third group (no premedication) is necessary in order to evaluate a placebo response, which may be significant on anxiety level and patients perceptions of care. It was calculated that 969 patients had to be included in order to obtain a 5 point difference between groups on the EVAN score with 80 % statistical power, leading to the inclusion of 1200 patients with an estimated maximum dropout rate of 15 %. All adults below 70 years and scheduled for elective surgery under general anesthesia can be included after information by an anesthesiologist in charge of the study and written informed consent. Non inclusion criterions are: a weight below 45 Kg, a counter indication to benzodiazepine, surgeries that could impair cognitive functions (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug addiction or former cognitive disease. The technique of anesthesia will be decided by the attending anesthesiologist, who will be unaware of the premedication technique, independently of the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: Placebo (microcrystalline celluloses)placebo |
| no premedication group | Active comparator | Other: no premedicationno premedication |
| Lorazepam group | Experimental | Drug: Lorazepamlorazepam |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male or female aged 18 to 70 years or more;
- About a weight greater than 45 kg;
- Subject to benefit from a scheduled surgery under general anesthesia;
- Topic respecting the ambivalence clause defined below:
- Topic able to complete a self-administered questionnaire;
Key exclusion criteria (13 listed)
- - Topic of over 70 years;
- Topic 45 kg or less;
- Topic demanding to receive anxiolytic premedication;
- Subject severe respiratory insufficiency;
- Topic minor, pregnant or breastfeeding, about not being affiliated to the social security system;
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 |
|---|---|---|
| Lorazepam | Drug | Lorazepam group |
| no premedication | Other | no premedication group |
| Placebo (microcrystalline celluloses) | Drug | placebo group |
Primary outcome
the EVAN score
Time frame: 2 years
to evaluate patient satisfaction of the perioperative period
1 secondary outcome
the perioperative level of anxiety
Time frame: 2 years
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 21 Apr 2015.
- Derived from this study: PubMed 25734733Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.
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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.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lorazepam and no premedication in people with Perioperative Anxiety, run by Assistance Publique Hopitaux De Marseille 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 9 inclusion and 13 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 21 Apr 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the EVAN score (time frame: 2 years). 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 NCT01901003, 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 21 Apr 2015.