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Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03323619
Acronym
DELIRIUMTAVI
Enrollment
200
Registered
2017-10-27
Start date
2017-11-02
Completion date
2020-11-02
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Aortic Valve Disease, Delirium, Post-Op Complication

Keywords

Transcatheter aortic valve replacement, Anesthesia technique, Delirium

Brief summary

Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II\> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure

Interventions

No intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Hospital admission for TAVI femoral way * Age \> 18 years * Psychiatric disease

Exclusion criteria

* Opposition of the operator (Interventional Cardiologist or Surgeon) to one of the two anesthesia technique * Contraindication to local anesthesia with sedation: agitation, delirium, allergy to local anesthetics, risk of inhalation * Opposition of the patient to use his data for research

Design outcomes

Primary

MeasureTime frameDescription
Delirium7 dayspost-operative delirium after TAVI

Secondary

MeasureTime frameDescription
ICU stay30 daysduration of stay in ICU

Countries

France

Contacts

Primary ContactFRITZ Caroline, MD
fritzcaro@gmail.com+33383157379
Backup ContactMATTEI Mathieu, MD
m.mattei@chru-nancy.fr+33383153521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026