Multimodal anesthesia for beating heart surgery

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Anesthesicts Multimodals methods for coronary artery surgery without extracorporeal circulation.

Secondary indentifying numbers:

SIDI 1650

Issuing authority of the secondary identifying numbers:

Surgical-Clinic Hermanos Ameijeiras Hospital

Source(s) of monetary or material support:

Surgical-Clinic Hermanos Ameijeiras Hospital

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Maria Oslaida Aguero Martinez, MD. 2nd Degree Specialist in Anesthesiology and Reanimation

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Surgical-Clinic Hermanos Ameijeiras Hospital, July 14, 2008

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

16/09/2008

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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).

Key secondary outcomes:

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).

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

No limit

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Single Blind

Control group:

Active

Study design:

Parallel

Phase:

2-3

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Rosa

Last Name:

Jimenez-Paneque

Affiliation:

Surgical- Clinic Hermanos Ameijeiras Hospital

Postal Address:

Stree San Lazaro,number 701, between Belascoain and Marquez Gonzalez

City:

Havana

País:

Cuba

Zip Code:

ZP 10300

Telephone:

537 8761626

Email :

rjimenez@infomed.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maria

Middle Name:

Oslaida

Last Name:

Aguero-Martinez

Affiliation:

Surgical-Clinic Hermanos Ameijeiras Hospital

Postal Address:

San Lázaro 701 , % Marquez Glez y Belascoain CP 10300 Havana city, Cuba.

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

537 6997351

Email :

osly@infomed.sld.cu [3]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000131

Date of Registration in Primary Registry:

2012-06-09

Record Verification Date:

2012-05-13 20:00

Link to the spanish version:

Click here [4]