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Multimodal anesthesia for beating heart surgery

Anesthesicts Multimodals methods for coronary artery surgery without extracorporeal circulation.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000131
Enrollment
90
Registered
2012-06-09
Start date
2008-09-16
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

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

Sponsors

Surgical-Clinic Hermanos Ameijeiras Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Cuba

Contacts

Public ContactRosa Jimenez-Paneque

Surgical- Clinic Hermanos Ameijeiras Hospital

rjimenez@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026