Status:
UNKNOWN
Study To Check The Analgesic And Anti-Inflammatory Effects Of Atorvastatin In Patients Undergoing Abdominal Surgery
Lead Sponsor:
B. J. Medical College, Pune
Conditions:
Abdominal Surgery
Eligibility:
All Genders
25-55 years
Phase:
PHASE3
Brief Summary
The study is planned to check the analgesic and anti-inflammatory properties of Atorvastatin in patients who will be undergoing abdominal surgery under spinal anesthesia. The investigators intend to m...
Detailed Description
Study type: Double Blind Placebo Controlled Method of Randomization: Computer Generated Table No. of patients to be recruited: 40 Accept Healthy Volunteers: No Drugs to be administered: Atorvastat...
Eligibility Criteria
Inclusion
- Male or female patients aged 25-55 years
- Patients who will be undergoing abdominal surgery under spinal anaesthesia
- Patients who will undergo non-bowel abdominal surgery with an abdominal incision
- Understands and agrees to comply with all study procedures including the daily treatments and follow-up visits
- Able to understand and is voluntarily willing to sign an informed consent form for this study
- Weight between 50 and 120 kg
Exclusion
- Bowel surgery or surgery under general anaesthesia
- Any emergency operations
- Surgery in patients in whom the chances of infection are very high. Example peritonitis, cystitis, appendical abscess, perforations, etc
- Laparoscopic Surgery
- Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- Any active Cancer
- Uncontrolled diabetes mellitis
- Untreated hypertension
- Psychotic disorder(s), dementia, mental retardation, or other organic mental disorders (subjects who are not mentally and physically able to personally consent for participation in this study are not eligible)
- Any other (including acute) condition, which in the opinion of the investigator, is likely to cause non-compliance or significantly impact treatment outcomes
- Sensitivity to the study drug or its components
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00902967
Start Date
July 1 2009
End Date
February 1 2010
Last Update
June 3 2009
Active Locations (1)
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1
Department of Pharmacology, Sassoon General Hospitals
Pune, Maharashtra, India, 411001