Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass

NCT ID: NCT02840006

Last Updated: 2016-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30

Brief Summary

CONTEXT: In patients eligible for coronary artery bypass surgery, anesthesia should provide a number of conditions that exceed the limits of cardiovascular stability, myocardial protection and other organs. Moreover, the combination of general anesthesia and spinal anesthesia lessens the homeostatic, metabolic, hormonal and immunosuppressive changes. The goal of this research was to evaluate the consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting (CABG) surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.

METHODS: Clinical, prospective, randomized and double covered study, approved by the Research Ethics Committee. Fifty-six patients candidates for CABG with CPB, after signing the Terms of consent, were randomized and divided into two groups: GI - General and GII - General + subarachnoid. General anesthesia was induced according to the weight of each patient and maintenance with isoflurane and fentanyl. Spinal anesthesia was induced with 20 mg of 0.5% hyperbaric bupivacaine and 200 mcg of morphine, the patient is placed in cephalo-position slope of 45 degrees for 10 minutes in Group II. In the statistical study was performed using the Mann-Whitney test; the level of statistical significance was set at 5%.

Conditions

Myocardial Revascularization; Spinal Anesthesia; Postoperative Care; Fentanyl

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

General anesthesia only

Anesthetic induction with etomidate 0,3 a 0,4 mg.kg-1, citrate fentanyl 5 mcg.kg-1 and atracurium 0,5.kg-1

Group Type: ACTIVE_COMPARATOR

General anesthesia only

Intervention Type: PROCEDURE

Induction drugs: Citrate of fentanyl, atracurium, etomidate

General anesthesia associated spinal anesthesia

spinal anesthesia using bupivacaine 0,5% hyperbaric 20 mg, morphine 200 mcg, set trendeleburg for 10 minutes, sensitive test in T1. Anesthetic induction with etomidate 0,3 a 0,4 mg.kg-1, citrate fentanyl 5 mcg.kg-1 and atracurium 0,5.kg-1.

Group Type: ACTIVE_COMPARATOR

General anesthesia and Spinal anesthesia

Intervention Type: PROCEDURE

Induction drugs: Citrate of fentanyl, atracurium, etomidate Spinal anesthesia: Bupivacaine hyperbaric, Morphine

Interventions

General anesthesia only

Induction drugs: Citrate of fentanyl, atracurium, etomidate

Intervention Type: PROCEDURE

General anesthesia and Spinal anesthesia

Induction drugs: Citrate of fentanyl, atracurium, etomidate Spinal anesthesia: Bupivacaine hyperbaric, Morphine

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients of both genders
• Underwent cardiac artery bypass surgery with cardiopulmonary bypass, with
• No restriction on age
• No restriction on ethnicity
• No restriction on education or social class

Exclusion Criteria

• Patients with sternotomy provided; those
• Urgent surgery and/or emergency
• Patient was with signs of shock
• Patients with chronic renal failure
• Patients with liver disorders
• Tracheostomy patients
• Patients with presence of use of mechanical ventilatory support;
• Patients with physical disabilities; bedridden and wheelchair users.
• Patients to withdraw the Consent and Informed
• Patients who eventually had to be re-operated in the presence also of the mechanical ventilatory support.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daniel Gioielli de Castilho

OTHER

Sponsor Role: lead

Responsible Party

Daniel Gioielli de Castilho

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital das Clinicas Samuel Libânio

Pouso Alegre, Minas Gerais, Brazil

Univas

Pouso Alegre, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

MEDC

Identifier Type: -

Identifier Source: org_study_id