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

Phase 1

• Conditions: Abdominal aortic aneurism; MedDRA version: 18.0Level: PTClassification code 10002885Term: Aortic aneurysm repairSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004604-29-DK
• Lead Sponsor: Jens Rolighed Larsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-04
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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