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NCT Number: NCT03917186

Desflurane vs. Sevoflurane in Endovascular Aortic Repair

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.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital general universitario Gregorio Marañón

Madrid, 28007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

administration of sevoflurane

Desflurane

Drug

administration of Desflurane

Primary outcomes

  1. Change in Biochemical parameters

    Time frame: All these parameters will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    NGAL in urine

  2. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    Cystatin C(mg/L) in plasma

  3. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    Creatinine(mg/dL) in plasma

  4. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    sodium(mMol/L) in plasma

  5. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    potassium(mMol/L) in plasma

  6. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    Chloride(mMol/L) in plasma

  7. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    albumin(g/dL) in plasma

  8. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    osmolarity(mOsm/Kg) in plasma

  9. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    NGAL in plasma

  10. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    Creatinine(mg/dL) in urine

  11. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    sodium(mMol/L) in urine

  12. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    potassium(mMol/L) in urine

  13. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    Chloride(mMol/L) in urine

  14. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    albumin(g/dL) in urine

  15. Change in Biochemical parameters

    Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups

    osmolarity(mOsm/Kg) in urine

Secondary outcomes

  1. Need for postoperative mechanical ventilation

    Time frame: 24 hours

    hours of mechanical ventilation in ICU

  2. ICU length of stay

    Time frame: up to 24 hours

    hours in ICU

  3. anesthetic recovery

    Time frame: 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)

    time to extubation(minutes).

  4. anesthetic recovery

    Time frame: 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).

    time to spontaneous eye opening(minutes)

  5. anesthetic recovery

    Time frame: 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).

    time until first response to verbal commands(minutes)

  6. anesthetic recovery

    Time frame: 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)

    The post-anesthesia recovery score ( Modified Aldrete score) (0-1-2 from worse to better)

Sponsors and collaborators

Lead sponsor

Begoña Quintana Villamandos

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 16, 2019
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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