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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypnosedation | Experimental | hypnosedation |
|
| general anesthesia | Other | general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypnosedation | Other | hypnosedation |
| |
| general anesthésia |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | on the 7th day following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| COLOMBANI Sylvie, MD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Strauss | Strasbourg | Alsace | 67000 | France | ||
| Institut Bergonié |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypnosedation | hypnosedation hypnosedation: hypnosedation |
| FG001 | General Anesthesia | general anesthesia general anesthésia: general anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypnosedation | hypnosedation hypnosedation: hypnosedation |
| BG001 | General Anesthesia | general anesthesia general anesthésia: general anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Participants who completed the questionnaire | Posted | Median | Inter-Quartile Range | score on a scale | on the 7th day following surgery |
|
Adverse events and serious adverse events were not collected.
Adverse events and serious adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypnosedation | hypnosedation hypnosedation: hypnosedation | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Simone Mathoulin-Pélissier | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | 0556333333 | s.mathoulin@bordeaux.unicancer.fr |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2009 | Dec 9, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006991 | Hypnosis, Anesthetic |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Other |
general anesthesia |
|
| Bordeaux |
| Aquitaine |
| 33000 |
| France |
| Centre Oscar Lambret | Lille | Nord | 59000 | France |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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) | Participants who completed the questionnaire | Posted | Median | Inter-Quartile Range | score on a scale | 1 month after surgery |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | General Anesthesia | general anesthesia general anesthésia: general anesthesia | 0 | 0 | 0 | 0 | 0 | 0 |
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