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OpenTrials
Completed

NCT Number: NCT02840006

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%.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital das Clinicas Samuel Libânio, Pouso Alegre, Minas Gerais, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General anesthesia only

Procedure

Induction drugs: Citrate of fentanyl, atracurium, etomidate

General anesthesia and Spinal anesthesia

Procedure

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

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.

    Time frame: in 24 hours

    Will be measure the consumption of fentanyl in 24 hours

Sponsors and collaborators

Lead sponsor

Daniel Gioielli de Castilho

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Jul 21, 2016
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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