Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass

Spinal Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840006
• Other study ID #: MEDC
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2016
• Last updated: July 20, 2016
• Start date: September 2014

Study information

• Verified date: July 2016
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Fentanyl
• Myocardial Revascularization
• Postoperative Care
• Spinal Anesthesia

Intervention

Procedure:
• General anesthesia only
Induction drugs: Citrate of fentanyl, atracurium, etomidate
• General anesthesia and Spinal anesthesia
Induction drugs: Citrate of fentanyl, atracurium, etomidate Spinal anesthesia: Bupivacaine hyperbaric, Morphine

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas Samuel Libânio	Pouso Alegre	Minas Gerais
Brazil	Univas	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Gioielli de Castilho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No