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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03917186
Other study ID # DESEVAR
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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