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UnknownNCT03323619

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

Status
Unknown
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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

Conditions

Interventions

TypeNameDescription
PROCEDUREanesthesia typeNo intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice

Timeline

Start date
2017-11-02
Primary completion
2020-08-02
Completion
2020-11-02
First posted
2017-10-27
Last updated
2018-09-06

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03323619. Inclusion in this directory is not an endorsement.

Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation (NCT03323619) · Clinical Trials Directory