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Desflurane vs. Sevoflurane in Endovascular Aortic Repair

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ClinicalTrials.gov Identifier: NCT03917186
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Begoña Quintana Villamandos, Hospital General Universitario Gregorio Marañon

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.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: Sevoflurane Drug: Desflurane Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Fast-track in Endovascular Aortic Aneurysm Repair With Desflurane and Sevoflurane: a Randomized Clinical Trial
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aortic Aneurysm

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917186


Contacts
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Contact: Begoña Quintana, PhD +34649265601 begoquinti@gmail.com

Locations
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Spain
Hospital general universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: BEGOÑA QUINTANA, PhD    34649265601    begoquinti@gmail.com   
Sponsors and Collaborators
Begoña Quintana Villamandos
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Begoña Quintana, PhD Hospital General Universitario Gregorio Marañón

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Responsible Party: Begoña Quintana Villamandos, Anesthesiologsit, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT03917186     History of Changes
Other Study ID Numbers: DESEVAR
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Begoña Quintana Villamandos, Hospital General Universitario Gregorio Marañon:
Desflurane, Sevoflurane, Endovascular aortic repair

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sevoflurane
Desflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs