Desflurane vs. Sevoflurane in Endovascular Aortic Repair

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917186
• Other study ID #: DESEVAR
• Status: Completed
• Phase: Phase 4
• Start date: September 20, 2017
• Est. completion date: March 16, 2021

Study information

• Verified date: November 2023
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Sevoflurane
administration of sevoflurane
• Desflurane
administration of Desflurane

Locations

Country	Name	City	State
Spain	Hospital general universitario Gregorio Marañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Begoña Quintana Villamandos	Baxter Healthcare Corporation

Country where clinical trial is conducted

Spain, 

Outcome

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)