Desflurane vs. Sevoflurane in Endovascular Aortic Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Drug: Sevoflurane; Drug: Desflurane

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Begoña Quintana, PhD; Phone Number: +34649265601; Email: begoquinti@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group sevoflurane; Administration under labelling conditions	Drug: Sevoflurane; administration of sevoflurane
Experimental: Group desflurane; Administration under labelling conditions	Drug: Desflurane; administration of Desflurane

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)

Collaborators and Investigators

• Sponsor: Begoña Quintana Villamandos
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Begoña Quintana, PhD, Hospital General Universitario Gregorio Marañon

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Desflurane, Sevoflurane, Endovascular aortic repair
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Desflurane; Sevoflurane
• Other Study ID Numbers: DESEVAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No