Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass

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%.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Postoperative Care; Fentanyl; Myocardial Revascularization
• Intervention / Treatment: Procedure: General anesthesia only; Procedure: General anesthesia and Spinal anesthesia

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Pouso Alegre, Minas Gerais, Brazil, 37550-000
      • Hospital das Clinicas Samuel Libanio
    • Pouso Alegre, Minas Gerais, Brazil, 37550-000
      • Univás

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: General anesthesia only; Induction drugs: Citrate of fentanyl, atracurium, etomidate
Active Comparator: 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.	Procedure: General anesthesia and Spinal anesthesia; Induction drugs: Citrate of fentanyl, atracurium, etomidate Spinal anesthesia: Bupivacaine hyperbaric, Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.	Will be measure the consumption of fentanyl in 24 hours	in 24 hours

Collaborators and Investigators

• Sponsor: Daniel Gioielli de Castilho

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Vasodilator Agents; Vasoconstrictor Agents
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: MEDC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes