Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | anesthesia type | No 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.