Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass

NCT02840006 | Completed Phase 4

• 1 other identifier: MEDC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

Vasoconstrictor Agents; Vasodilator Agents

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

General anesthesia only

ACTIVE COMPARATOR

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

General anesthesia associated spinal anesthesia

ACTIVE COMPARATOR

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

Interventions

General anesthesia only PROCEDURE

Induction drugs: Citrate of fentanyl, atracurium, etomidate

General anesthesia only

General anesthesia and Spinal anesthesia PROCEDURE

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

General anesthesia associated spinal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Gioielli de Castilho: lead

Study Sites (2)

Hospital das Clinicas Samuel Libânio

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

Univas

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Interventions

Anesthesia, General; Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 21, 2016
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Last Updated: July 21, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (2)