Sevoflurane versus standard general anesthesia in elective open abdominal aortic aneurism surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004604-29-DK

Enrollment

Registered

2015-03-04

Start date

2015-04-27

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal aortic aneurism MedDRA version: 18.0 Level: PT Classification code 10002885 Term: Aortic aneurysm repair System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Sevoflurane Product Name: Sevoflurane Pharmaceutical Form: Inhalation vapour INN or Proposed INN: Sevoflurane CAS Number: 28523-86-6 Other descriptive name: SEVOFLURANE Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients enrolled for surgery for abdominal infrarenal aortic aneurism repair, Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: Patients under 18 years of age Patients included in other pharmaceutical studies Abuse of opioids, benzodiazepines, anti epileptic drugs, alcohol and alpha 2-agonists Pregnant and breastfeeding women Patients with family history of malignant hyperthermia Patients with known hypersensitivity for opioids, propofol or volatile anesthetics Patients with serious arrhythmias; ventricular tachycardia or tachycardia >120 beats/min Patients with severe valvular diseases requiring surgical repair before major non cardiac surgery Patients with uncontrolled hypertension Patients with unstable angina pectoris or MI within 30 days of inclusion Patients requiring acute abdominal aortic aneurysm surgery Planned endovascular abdominal aortic aneurysm surgery Patients with servere uncontrolled psychiatric disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate wether Sevoflurane is superior to Propofol in open aortic aneurism repair;Secondary Objective: Not applicable;Primary end point(s): NT-proBNP, cystatin C, u-NGAL, D-lactate, cTnT, L-lactate, GST, s-ACE, IL-6, TNF-alpha, PaO2/FIO2 ratio, s-creatinine, AST, ALT, LDH and s-NGAL ;Timepoint(s) of evaluation of this end point: for biochemical 4 measurements within the first 72 hours.	—

Measure

Time frame

Main Objective: To evaluate wether Sevoflurane is superior to Propofol in open aortic aneurism repair;Secondary Objective: Not applicable;Primary end point(s): NT-proBNP, cystatin C, u-NGAL, D-lactate, cTnT, L-lactate, GST, s-ACE, IL-6, TNF-alpha, PaO2/FIO2 ratio, s-creatinine, AST, ALT, LDH and s-NGAL ;Timepoint(s) of evaluation of this end point: for biochemical 4 measurements within the first 72 hours.

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Secondary

Measure	Time frame
Secondary end point(s): -Need for inotropic support -Myocardial ischemia -Intestinal ischemia diagnosed with endoscopy, laparascopy or angiograf during admission. -Postoperative incidens of ARD and need of dialysis. ARD is defined according to the RIFLE criteria -Need for postoperative respiratorsupport. -Days until discharge. -Days at ICU. -30 day mortality ;Timepoint(s) of evaluation of this end point: After 30 days postoperatively.	—

Measure

Time frame

Secondary end point(s): -Need for inotropic support -Myocardial ischemia -Intestinal ischemia diagnosed with endoscopy, laparascopy or angiograf during admission. -Postoperative incidens of ARD and need of dialysis. ARD is defined according to the RIFLE criteria -Need for postoperative respiratorsupport. -Days until discharge. -Days at ICU. -30 day mortality ;Timepoint(s) of evaluation of this end point: After 30 days postoperatively.

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Countries

Denmark

Contacts

Public ContactPeder Bach

Peder Bach

pedebach@rm.dk004521748682

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026