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Clinical Trials/EUCTR2014-004604-29-DK
EUCTR2014-004604-29-DK
Active, not recruiting
Phase 1

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

Jens Rolighed Larsen0 sites24 target enrollmentMarch 4, 2015
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ConditionsAbdominal aortic aneurismMedDRA version: 18.0Level: PTClassification code 10002885Term: Aortic aneurysm repairSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsSevofluranePropofol B.Braun

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Abdominal aortic aneurism
Sponsor
Jens Rolighed Larsen
Enrollment
24
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 4, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Jens Rolighed Larsen

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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