Patients With Breast Cancer and Breast Surgery RequiringHYPNOSEINNCT01880541
Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer
A study testing hypnosedation and general anesthésia in people with Patients With Breast Cancer and Breast Surgery Requiring, run by Institut Bergonié at 3 sites in France.
Trial summary
The emergence of cognitive disorders after surgery under general anesthesia (GA) is the second leading cause of patient complaints (after dental debris caused by intubation techniques). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients With Breast Cancer and Breast Surgery Requiring
- What is being tested?
- hypnosedation and general anesthésia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2010to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, over 18 and under 80 years
- Diagnosis of breast cancer established (Pathology)
- Life expectancy greater than 6 months
- Surgery of breast lumpectomy with or without lymph node dissection, mastectomy with or without lymph node dissection, dissection isolated
- ASA 1 (healthy patient) or 2 (patient with moderate to high function) according to the classification of the American Society of Anesthesiologist,
- Affiliation to a social security scheme,
- Information on the study, signed informed consent
Who cannot join
- Presence of major psychiatric disorders or psychotic behavior addiction, evaluated by neuropsychologist at the first preoperative consultation, through the test MINI (MINI> 4 positive responses for each module)
- Presence of neurological disorders known untreated or evaluated by neuropsychologist at the first preoperative consultation, with the MMSE test (MMSE <24)
- Patient treated morphine orally for 3 months or more
- Patient is pregnant or nursing, or of childbearing potential and not using adequate contraception,
- Patient included in another clinical study
- Inability to undergo medical monitoring study for geographical, social or psychological
- Patient deprived of liberty and most subject to a measure of legal protection or unable to consent
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Bergonié
Bordeaux, Aquitaine, 33000
Centre Oscar Lambret
Lille, Nord, 59000
Centre Paul Strauss
Strasbourg, Alsace, 67000
About this study
Official title: Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer
The emergence of cognitive disorders after surgery under general anesthesia (GA) is the second leading cause of patient complaints (after dental debris caused by intubation techniques). These cognitive disorders can range from simple reversible confusion (26%) with postoperative cognitive dysfunction without actual recovery (10%).
The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive function remain to this day unknown, but appear promising.
Read the detailed description
For twenty years, hypnosedation is offered to patients who underwent surgery as an alternative to other anesthetic techniques (general anesthesia and locoregional), in some European and Anglo-Saxon hospitals for specific surgical indications (surgery area). It is commonly used in some hospitals.
The hypnosedation is little used in oncology
The hypnosedation is a hypnosis technique suitable for anesthesia, namely the one associated with intravenous conscious sedation and local anesthesia hypnosis. This derived from medical hypnosis Ericksoniene technique is divided into three stages:
- induction
- Deepening trance
- Déhypnotisation.
This technique is currently being validated and used at national and international level, in fact it is based on 500 references and appears in the national nomenclature of the Common Classification of Medical Procedures in the code ANRP 001, states: hypnosis referred to analgesic.
- Being tested
- hypnosedation, general anesthésia
- Keywords
- Patients with breast cancer and breast surgery requiring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosedationOther
hypnosedation
general anesthésiaOther
general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| hypnosedation | Experimental | hypnosedation Receives: Other: hypnosedation |
| general anesthesia | Other | general anesthesia Receives: Other: general anesthésia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Cognitive Impairment
Cognitive impairment is assessed using the MMSE questionnaire (MINI-MENTAL STATE EXAMINATION). the MMSE total score ranges from 0 (alteration of cognition) to 30 (no alteration)
Measured: on the 7th day following surgery
Secondary outcomes (1)
Presence of Cognitive Impairment
Cognitive impairment is assessed using the MMSE questionnaire (MINI-MENTAL STATE EXAMINATION) The MMSE total score ranges from 0 (alteration of cognition) to 30 (no alteration)
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startDec 2010
- Primary completionNov 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patients With Breast Cancer and Breast Surgery RequiringStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- COLOMBANI Sylvie, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880541
- Sponsor's protocol ID
- IB2009-71
- Acronym
- HYPNOSEIN
- Status last verified
- Dec 2021
- First submitted
- 6 Nov 2012
- Last updated
- 4 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer
- ClinicalTrials.gov ID
- NCT01880541
- Acronym / sponsor ID
- HYPNOSEIN / IB2009-71
- Keywords
- Patients with breast cancer and breast surgery requiring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Posted 4 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The emergence of cognitive disorders after surgery under general anesthesia (GA) is the second leading cause of patient complaints (after dental debris caused by intubation techniques). These cognitive disorders can range from simple reversible confusion (26%) with postoperative cognitive dysfunction without actual recovery (10%).
The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive function remain to this day unknown, but appear promising.
Detailed description
For twenty years, hypnosedation is offered to patients who underwent surgery as an alternative to other anesthetic techniques (general anesthesia and locoregional), in some European and Anglo-Saxon hospitals for specific surgical indications (surgery area). It is commonly used in some hospitals.
The hypnosedation is little used in oncology
The hypnosedation is a hypnosis technique suitable for anesthesia, namely the one associated with intravenous conscious sedation and local anesthesia hypnosis. This derived from medical hypnosis Ericksoniene technique is divided into three stages:
- induction
- Deepening trance
- Déhypnotisation.
This technique is currently being validated and used at national and international level, in fact it is based on 500 references and appears in the national nomenclature of the Common Classification of Medical Procedures in the code ANRP 001, states: hypnosis referred to analgesic.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypnosedation | Experimental | Other: hypnosedationhypnosedation |
| general anesthesia | Other | Other: general anesthésiageneral anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, over 18 and under 80 years
- Diagnosis of breast cancer established (Pathology)
- Life expectancy greater than 6 months
- Surgery of breast lumpectomy with or without lymph node dissection, mastectomy with or without lymph node dissection, dissection isolated
- ASA 1 (healthy patient) or 2 (patient with moderate to high function) according to the classification of the American Society of Anesthesiologist,
Key exclusion criteria (7 listed)
- Presence of major psychiatric disorders or psychotic behavior addiction, evaluated by neuropsychologist at the first preoperative consultation, through the test MINI (MINI> 4 positive responses for each module)
- Presence of neurological disorders known untreated or evaluated by neuropsychologist at the first preoperative consultation, with the MMSE test (MMSE <24)
- Patient treated morphine orally for 3 months or more
- Patient is pregnant or nursing, or of childbearing potential and not using adequate contraception,
- Patient included in another clinical study
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 |
|---|---|---|
| hypnosedationhypnosedation | Other | hypnosedation |
| general anesthésiageneral anesthesia | Other | general anesthesia |
Primary outcome
Presence of Cognitive Impairment
Time frame: on the 7th day following surgery
Cognitive impairment is assessed using the MMSE questionnaire (MINI-MENTAL STATE EXAMINATION). the MMSE total score ranges from 0 (alteration of cognition) to 30 (no alteration)
1 secondary outcome
Presence of Cognitive Impairment
Time frame: 1 month after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
COLOMBANI Sylvie, MD study chair
Institut Bergonié
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnosedation and general anesthésia in people with Patients With Breast Cancer and Breast Surgery Requiring, run by Institut Bergonié at 3 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 7 inclusion and 7 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Presence of Cognitive Impairment (time frame: on the 7th day following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2022.