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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01461551
Other study ID # OPCAB
Secondary ID
Status Completed
Phase N/A
First received October 19, 2011
Last updated May 6, 2015
Start date October 2011
Est. completion date October 2014

Study information

Verified date May 2015
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date October 2014
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- male adults

- aged 18-80 yr

- undergoing elective OPCAB surgery containing left anterior descending artery bypass

Exclusion Criteria:

- a previous unusual response to any of the experimental anesthetics

- severe cardiac dysrhythmias or ejection fraction below 30%

- hemodynamic instability

- previous surgical coronary artery repair

- anemia, abnormal leukocytes or coagulopathy

- severe hypertension

- severe hepatic (albumin<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions

- concomitant surgical procedures and psychiatric disorders

- Insulin-dependent diabetics

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane
anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
Propofol
anesthesia was maintained with propofol (2-4 µg/ml via target-controlled infusion)
combine of sevoflurane and propofol
anesthesia was maintained with a combine of propofol (1 µg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)

Locations

Country Name City State
China Ruijin Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lymphocyte Count Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures. 1 day after surgery Yes
Secondary Intensive Care Unit Staying Days participants will stay in intensive care unit after surgery, an expected average of 2 days Yes
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