Assessment of the possible protective effect of anesthetics on the heart in patients undergoing cardiac surgery.

Phase 1

• Conditions: Cardiac surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-003413-10-ES
• Lead Sponsor: FIMABIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-09
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age = 18 year old.
2. Elective off-pump coronary artery bypass surgery.
3. EUROSCORE (European level of risk, useful in the perioperative period of patients undergoing cardiac surgery, validated at medical and scientific level) under 8 (cardiological moderate risk in the perioperative).
4. Degree of anesthetic risk according to the American Society of Anesthesiologists (ASA) less than 4 (moderate-risk patient high anesthetic).
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 128
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of adverse reaction to anesthetic drugs.
2. Severe illness of any organ (lung, liver, kidney), diagnosed preoperatively.
3. Combined surgery (eg valve repair or carotid surgery).
4. Patients in situations of hemodynamic instability.
5. Heart failure or need for use of inotropes or vasoactive pre-intervention.
6. Treatment with oral antidiabetic drugs at least 48 hours before.
7. Pre-intervention treatment with eufilina/theophylline.
8. Inability to grant informed consent.
9. Pregnancy or breastfeeding.

Study & Design

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