Renal Failure Clinical Trial
Official title:
Fast-track in Endovascular Aortic Aneurysm Repair With Desflurane and Sevoflurane: a Randomized Clinical Trial
Verified date | November 2023 |
Source | Hospital General Universitario Gregorio Marañon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | March 16, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital general universitario Gregorio Marañón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Begoña Quintana Villamandos | Baxter Healthcare Corporation |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Need for postoperative mechanical ventilation | hours of mechanical ventilation in ICU | 24 hours | |
Secondary | ICU length of stay | hours in ICU | up to 24 hours | |
Secondary | 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) | |
Secondary | 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). | |
Secondary | 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). | |
Secondary | 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) |
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