Multimodal anesthesia for beating heart surgery

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000131
• Date of registration: 09/06/2012
• Primary sponsor: Surgical-Clinic Hermanos Ameijeiras Hospital
• Public title: Multimodal anesthesia for beating heart surgery
• Scientific title: Anesthesicts Multimodals methods for coronary artery surgery without extracorporeal circulation.
• Date of first enrolment: 16/09/2008
• Target sample size: 90
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000131-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Single Blind Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Maria Aguero-Martinez
• Affiliation: Surgical-Clinic Hermanos Ameijeiras Hospital

• Name: Rosa Jimenez-Paneque
• Affiliation: Surgical- Clinic Hermanos Ameijeiras Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1.Without previous cardiac surgery. 2.Ejection fraction >45 % without need of intra-aortic balloon pump support. 3.Without dysrhythmias. 4.Consciousness-awake and alert and without neurologic deficiency. 5.Urine output >0.5ml/kg and creatinine under 132 mmol/l. 6.Normal chest x-ray findings.
Exclusion criteria: 1.No consent. 2.Absolute contraindication of regional anesthesia. 3.Acute (less than 7 days of evolutions) or recent (less than 30 days) myocardial infarction. 4.Used of inotropic drug. 5.Sings of heart failure. 6.Middle or severe Lung Hypertension. 7.Chronic obstructive lung disease.

Age minimum: 18 years
Age maximum: No limit
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary artery disease

Intervention(s)

Study Group 1 (Multimodal anesthetic method): + General Anesthesia Intrathecal administration of opioids General anesthesia. Fentanyl induction with 5 mg / kg body weight + midazolam 0.2 mg / kg body weight + Atracurium Besylate 0.5 mg / kg body weight. Maintenance with isoflurane (between 0.1 percent and volume) via orotracheal + propofol 50 mg / kg / min in continuous infusion + atracurium of 5 mg / kg / min in continuous infusion) Intrathecal administration of opioids (fentanyl, 1 mg / kg body weight + morphine, 8µg/kg) Study Group 2 (Multimodal anesthetic method): General anesthesia + thoracic epidural block General anesthesia. Identical to Study Group 1 Thoracic epidural (bupivacaine 0.5% 10 ml + 5 mg of morphine). Control group: General Anesthetic: General anesthesia. Identical to Study Group 1

Primary Outcome(s)

Postoperative analgesia (Pain intensity using a Visual Analog Scale). Measurement time: 1 hour (h), 2h , 3h, 4h, 12h, 24h, 48h and 72h after the extubation of the patient. Total doses of morphine used in the postoperative period (mg).Measurement time: At leave to the postoperative intensive care unit. Time to extubation (Hours between the end of the surgery and the extubation of the patient).

Secondary Outcome(s)

Intraoperative analgesia (Hemodynamic changes in mean arterial blood pressure and heart rate during the incision of the skin, sternotomy and pericardiotomy). Measurement time: At the end of surgery Total doses of fentanyl used in the period (in micrograms). Measurement time: At the end of surgery. Adverse Events related to Opioid treatment (Yes/No). Measurement time: every 24 hour until hospital discharge. Perioperative complications (Yes/No). Measurement time: each 24 hour until hospital discharge. Complications associated with the use of regional anesthesia (Yes/No). Measurement time: every 24 hour until hospital discharge. Cost in the Intensive Care Unit (ICU). Measurement time: At leave the ICU ICU cost per day: Cost of a bed day per patient in ICU. Value used by the Economic department of the clinical site, 700 CUC per day). Cost in the hospital stay (including the days between ICU dischage until hospital discharge). Measurement time: At hospital discharge. The hospital stay cost per day: cost per day per patient from a bed in room. Value used by the Economic department of the clinical site, 350 CUC per day).

Secondary ID(s)

SIDI 1650

Source(s) of Monetary Support

Surgical-Clinic Hermanos Ameijeiras Hospital

Secondary Sponsor(s)

Not applicable