Evaluation of anesthesia in cardiac surgery patients

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-8m444q
• Date of registration: 09/03/2012
• Primary sponsor: Universidade Federal do Rio Grande do Norte - Natal, RN, Brazil
• Public title: Evaluation of anesthesia in cardiac surgery patients
• Scientific title: Evaluation of the analgesic efficacy of general and spinal anesthesia with morphine associated ropivacaine in patients who underwent surgery type coronary artery bypass grafting
• Date of first enrolment: 15/03/2012
• Target sample size: 58
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-8m444q/
• Study design: Therapeutic, parallel, two arms, single-blind, randomized, clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Valdecy Pinheiro
• Affiliation: Universidade Federal do Rio Grande do Norte

• Name: Valdecy Pinheiro
• Affiliation: Universidade Federal do Rio Grande do Norte

Key inclusion & exclusion criteria

Inclusion criteria: Assessment of the physical status;
Anesthetic risk classification according to the American Society of Anesthesiologists (ASA) ASA II and III;
The indication of coronary artery bypass grafting;
Verbal skills and understanding appropriate to participate in the interview; - No pain preoperatively.
Exclusion criteria: Manifestation of the patient and / or guardian's desire not to continue in the study;
Present severe postoperative complications such as respiratory and heart failure, valvular heart disease associated procedures and emergencies, reoperation;
Other disorders pre-operative treatment with heparin, since it may affect patients' responses to questions about pain.

Age minimum: 40Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Chronic ischemic heart disease, unspecified
I25.9

Intervention(s)

In the experimental group, composed of 30 subjects, subarachnoid puncture is performed with patient in sitting position, after infiltration before skin and subcutaneous tissue with lidocaine 2% without epinephrine, 3 to 5 ml. After the puncture, held-to spinal median L3 or L4, needle number 25 to 27, the first morphine injection at a dose of 400mg; second injection of 0.6 ml ropivacaine, 0.5% hyperbaric with 3ml doubly distilled water. After 15 minutes, it will elevate the lower limbs. Then begins the induction of general anesthesia with Diprivan A (diprifusor) of 40mg/ml, sulfetanil and pancuronium 0.1 mg / kp, maintenance diprivam around 20 to 40 mg / ml and muscle relaxation with pancuronium 0.1 mg / kg 1 / 1 hour with 25% of the initial dose, followed by tracheal intubation with low-volume cuff and low pressure. Positioning of the tracheal tube is confirmed by auscultation and capnography in the presence of wave.
In the active control group, composed of 28 subjects, will perform general anesthesia alone, following the same pattern as the experimental group without spinal puncture.

Primary Outcome(s)

Improvement of the pain intensity, measured by the visual analogue scale (VAS), with scores ranging from 0 to 10 where 0 indicates no pain and 10 to give maximum.

Improves the quality of painmeasured by the McGill pain scale that assesses the painful experience in the dimensions: sensory, affective and evaluative and is based on words that patients select to describe their pain.
Reduction of the location of pain, measured by direct question to the respondent.

Secondary Outcome(s)

Reduced time to wake analyzed by checking the record time in the patient. Increased time for the request of analgesic analyzed by checking the record time in the patient. Absence or diminution of thoracic drains analyzed by visualization after the intervention. Absence or reduction of hyperemia before removal of drains by viewing the time of chest removal of the drain. Reduction of pain intensity in the removal of drains, measured by visual analog scale. Decrease in analgesic consumption measured by the amount of drugs consumed by the patient

Secondary ID(s)

186-05

Source(s) of Monetary Support

Promater Hospital Geral - Natal, RN, Brazil

Universidade Federal do Rio Grande do Norte - Natal, RN, Brazil

Secondary Sponsor(s)

Promater Hospital Geral - Natal, RN, Brazil