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

• Conditions: Delirium; Post-Op Complication; Aortic Valve Disease; Anesthesia
• Interventions: Procedure: anesthesia type

• Registration Number: NCT03323619
• Lead Sponsor: Central Hospital, Nancy, France

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Study Start: 2017-11-02
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06
• Primary Completion: 2020-08-02
• Study Completion: 2020-11-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LASed	anesthesia type	No intervention. Local anesthesia with sedation is decided by the physicien according to his usual practice
GA	anesthesia type	No intervention. General anesthesia is decided by the physicien according to his usual practice

Primary Outcome Measures

Name	Time	Method
Delirium	7 days	post-operative delirium after TAVI

Secondary Outcome Measures

Name	Time	Method
ICU stay	30 days	duration of stay in ICU

Trial Locations

Locations (1)

CHRU - Hopital de Brabois; 🇫🇷 Nancy, Lorraine, France