NCT03917186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2021

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

September 25, 2017

Last Update Submit

November 20, 2023

Conditions

Renal Failure

Keywords

Desflurane, Sevoflurane, Endovascular aortic repair

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (6)

  • Need for postoperative mechanical ventilation

    24 hours

  • ICU length of stay

    up to 24 hours

  • anesthetic recovery

    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

    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

    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).

  • +1 more secondary outcomes

Study Arms (2)

Group sevoflurane

ACTIVE COMPARATOR

Administration under labelling conditions

Drug: Sevoflurane

Group desflurane

EXPERIMENTAL

Administration under labelling conditions

Drug: Desflurane

Interventions

SevofluraneDRUG

administration of sevoflurane

Group sevoflurane
DesfluraneDRUG

administration of Desflurane

Group desflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 18 years undergoing elective endovascular aortic repair
  • who have signed informed consent

You may not qualify if:

  • urgent surgery
  • with known hypersensitivity to Desflurane or Sevoflurane.
  • Renal failure in hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital general universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (1)

  • Arnalich-Montiel A, Barrio-Perez IM, Burgos-Santamaria A, Fernandez-Riveira C, Lazaro A, Gonzalez-Nicolas MA, Rio J, Bellon JM, Canal MI, Ligero JM, Quintana-Villamandos B. Influence of the type of volatile anesthetic on the development of acute kidney injury after endovascular repair of aortic aneurysm: a randomized controlled trial (DESEVAR study). Front Pharmacol. 2025 Sep 25;16:1660359. doi: 10.3389/fphar.2025.1660359. eCollection 2025.

    PMID: 41079741DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

SevofluraneDesflurane

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Begoña Quintana, PhD

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologsit

Study Record Dates

First Submitted

September 25, 2017

First Posted

April 16, 2019

Study Start

September 20, 2017

Primary Completion

December 31, 2020

Study Completion

March 16, 2021

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

ES(1)