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Desflurane vs. Sevoflurane in Endovascular Aortic Repair

Primary Purpose

Renal Failure

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Sponsored by
Begoña Quintana Villamandos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Failure focused on measuring Desflurane, Sevoflurane, Endovascular aortic repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital general universitario Gregorio MarañónRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group sevoflurane

Group desflurane

Arm Description

Administration under labelling conditions

Administration under labelling conditions

Outcomes

Primary Outcome Measures

Change in Biochemical parameters
NGAL in urine
Change in Biochemical parameters
Cystatin C(mg/L) in plasma
Change in Biochemical parameters
Creatinine(mg/dL) in plasma
Change in Biochemical parameters
sodium(mMol/L) in plasma
Change in Biochemical parameters
potassium(mMol/L) in plasma
Change in Biochemical parameters
Chloride(mMol/L) in plasma
Change in Biochemical parameters
albumin(g/dL) in plasma
Change in Biochemical parameters
osmolarity(mOsm/Kg) in plasma
Change in Biochemical parameters
NGAL in plasma
Change in Biochemical parameters
Creatinine(mg/dL) in urine
Change in Biochemical parameters
sodium(mMol/L) in urine
Change in Biochemical parameters
potassium(mMol/L) in urine
Change in Biochemical parameters
Chloride(mMol/L) in urine
Change in Biochemical parameters
albumin(g/dL) in urine
Change in Biochemical parameters
osmolarity(mOsm/Kg) in urine

Secondary Outcome Measures

Need for postoperative mechanical ventilation
hours of mechanical ventilation in ICU
ICU length of stay
hours in ICU
anesthetic recovery
time to extubation(minutes).
anesthetic recovery
time to spontaneous eye opening(minutes)
anesthetic recovery
time until first response to verbal commands(minutes)
anesthetic recovery
The post-anesthesia recovery score ( Modified Aldrete score) (0-1-2 from worse to better)

Full Information

First Posted
September 25, 2017
Last Updated
August 14, 2020
Sponsor
Begoña Quintana Villamandos
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03917186
Brief Title
Desflurane vs. Sevoflurane in Endovascular Aortic Repair
Official Title
Fast-track in Endovascular Aortic Aneurysm Repair With Desflurane and Sevoflurane: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Begoña Quintana Villamandos
Collaborators
Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Desflurane, Sevoflurane, Endovascular aortic repair

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group sevoflurane
Arm Type
Active Comparator
Arm Description
Administration under labelling conditions
Arm Title
Group desflurane
Arm Type
Experimental
Arm Description
Administration under labelling conditions
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
administration of sevoflurane
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
administration of Desflurane
Primary Outcome Measure Information:
Title
Change in Biochemical parameters
Description
NGAL in urine
Time Frame
All these parameters will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
Cystatin C(mg/L) in plasma
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
Creatinine(mg/dL) in plasma
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
sodium(mMol/L) in plasma
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
potassium(mMol/L) in plasma
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
Chloride(mMol/L) in plasma
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
albumin(g/dL) in plasma
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
osmolarity(mOsm/Kg) in plasma
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
NGAL in plasma
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
Creatinine(mg/dL) in urine
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
sodium(mMol/L) in urine
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
potassium(mMol/L) in urine
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
Chloride(mMol/L) in urine
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
albumin(g/dL) in urine
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Title
Change in Biochemical parameters
Description
osmolarity(mOsm/Kg) in urine
Time Frame
will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Secondary Outcome Measure Information:
Title
Need for postoperative mechanical ventilation
Description
hours of mechanical ventilation in ICU
Time Frame
24 hours
Title
ICU length of stay
Description
hours in ICU
Time Frame
up to 24 hours
Title
anesthetic recovery
Description
time to extubation(minutes).
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)
Title
anesthetic recovery
Description
time to spontaneous eye opening(minutes)
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).
Title
anesthetic recovery
Description
time until first response to verbal commands(minutes)
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).
Title
anesthetic recovery
Description
The post-anesthesia recovery score ( Modified Aldrete score) (0-1-2 from worse to better)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Begoña Quintana, PhD
Phone
+34649265601
Email
begoquinti@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Begoña Quintana, PhD
Organizational Affiliation
Hospital General Universitario Gregorio Marañón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital general universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BEGOÑA QUINTANA, PhD
Phone
34649265601
Email
begoquinti@gmail.com

12. IPD Sharing Statement

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Desflurane vs. Sevoflurane in Endovascular Aortic Repair

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