Desflurane vs. Sevoflurane in Endovascular Aortic Repair

Study Overview
=================
Brief Summary
-----------------
Randomized Clinical Trial following the evaluation of the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery.

Detailed Description
-----------------
Randomized Clinical Trial to evaluate the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery. Secondary Endpoint: Among secondary endpoints we will evaluate clinical variables such emergence and recovery characteristics (time to extubation and time to emergence-open eyes and response to verbal command), the need for postoperative mechanical ventilation, the post-anesthesia recovery score and ICU length of stay.

Official Title
-----------------
Fast-track in Endovascular Aortic Aneurysm Repair With Desflurane and Sevoflurane: a Randomized Clinical Trial

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Desflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years undergoing elective endovascular aortic repair who have signed informed consent Exclusion Criteria: urgent surgery with known hypersensitivity to Desflurane or Sevoflurane. Renal failure in hemodialysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group sevoflurane<br>Administration under labelling conditions | Drug: Sevoflurane<br>* administration of sevoflurane<br>|
| Experimental: Group desflurane<br>Administration under labelling conditions | Drug: Desflurane<br>* administration of Desflurane<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Biochemical parameters | NGAL in urine | All these parameters will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | Cystatin C(mg/L) in plasma | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | Creatinine(mg/dL) in plasma | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | sodium(mMol/L) in plasma | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | potassium(mMol/L) in plasma | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | Chloride(mMol/L) in plasma | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | albumin(g/dL) in plasma | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | osmolarity(mOsm/Kg) in plasma | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | NGAL in plasma | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | Creatinine(mg/dL) in urine | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | sodium(mMol/L) in urine | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | potassium(mMol/L) in urine | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | Chloride(mMol/L) in urine | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | albumin(g/dL) in urine | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 
| Change in Biochemical parameters | osmolarity(mOsm/Kg) in urine | will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for postoperative mechanical ventilation | hours of mechanical ventilation in ICU | 24 hours | 
| ICU length of stay | hours in ICU | up to 24 hours | 
| anesthetic recovery | time to extubation(minutes). | These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded at baseline and after surgery. time frame upto 1 hour(stimated) | 
| anesthetic recovery | time to spontaneous eye opening(minutes) | These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded after surgery. timeframe up to 1 hour(stimated). | 
| anesthetic recovery | time until first response to verbal commands(minutes) | These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded after surgery. timeframe up to 1 hour(stimated). | 
| anesthetic recovery | The post-anesthesia recovery score ( Modified Aldrete score) (0-1-2 from worse to better) | These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded at baseline and after surgery. timeframe 1 hour(stimated) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Desflurane, Sevoflurane, Endovascular aortic repair