Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804002973186 Date of Approval: 14/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Change in Liver Enzymes After General or Spinal Anesthesia in Patients With Preoperatively Elevated Liver Enzymes
Official scientific title Comparative Study of the Change in Liver Enzymes After General or Spinal Anesthetic Techniques in Patients With Preoperatively Elevated Liver Enzymes
Brief summary describing the background and objectives of the trial To assess the changes in liver functions postoperatively in patients with preoperatively elevated liver enzymes. To identify the most appropriate anesthesia technique for patients with preoperatively elevated liver enzymes. To assess the effect of intraoperative event (bleeding, hypoxia, hypotension, prolonged operation) on liver functions in these patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Liver Enzymes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/10/2017
Actual trial start date 22/10/2017
Anticipated date of last follow up 28/01/2018
Actual Last follow-up date 08/02/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 24 hours Group A General anesthesia technique is used 30 Active-Treatment of Control Group
Experimental Group Group B 24 hours Procedure/Surgery: General anesthesia general anesthesia and regional anesthesia techniques are used 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult healthy ASA I, II patients, both genders, aged 18 ¿ 60 years, with stationary elevated liver enzymes < 2 folds undergoing elective lower abdominal wall or limb surgeries with expected operation time less than 2 hours ¿ ASA class III or IV ¿ Age >60 years or <18 years ¿ Patients undergoing intraperitoneal and laparoscopic procedures. ¿ Acute viral hepatitis: inflammation of the liver caused by infection with one of the five hepatitis viruses. In most people, the inflammation begins suddenly and lasts only a few weeks. ¿ Acute alcoholic hepatitis: is inflammation of the liver due to excessive intake of alcohol. It is usually found in association with fatty liver, an early stage of alcoholic liver disease, and may contribute to the progression of fibrosis, leading to cirrhosis. ¿ Severe chronic hepatitis: is inflammation of the liver that lasts at least 6 months. ¿ Child¿s C class classification: this score is used to assess the prognosis of chronic liver disease, mainly cirrhosis. ¿ Severe coagulopathy: a pathological condition that reduces the ability of the blood to coagulate, resulting in uncontrolled bleeding. A platelet count of < 50 x 109 /L will be considered at high risk of increased bleeding. ¿ Severe extrahepatic complication (Hypoxemia, Acute renal failure¿) ¿ Pregnant, diabetic patients ¿ Patients having an auto-immune disease ¿ Patients taking anticoagulant drugs or drugs that cause elevated liver enzymes (non-steroidal anti-inflammatory drugs, antibiotics, antiepileptic drugs, inhibitors of hydroxyl-methyl-glutaryl¿coenzyme a reductase (statins), and anti-tuberculosis drugs) were excluded from the study 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/02/2017 Cairo University Medical Faculty
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy Cairo N30-2017/Ms Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Compare the pre and postoperative liver enzymes 1. Compare the pre and postoperative liver enzymes ¿To compare the pre and 24 hours postoperative AST levels of patients in the general anaesthesia group and spinal anaesthesia group [Time Frame: Through study completion and 24 hours postoperatively]
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr Alainy Hospitals Kasr Alainy Cairo N30-2017/Ms Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kasr Alainy Hospitals Kasr Alainy Cairo N30-2017/Ms Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Kasr Alainy Hospitals Kasr Alainy Cairo N30-2017/Ms Egypt Hospital
Primary Sponsor Cairo University Cairo University Square Cairo N30-2017/Ms Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Mostafa Gomaa Kasr Alainy Cairo N30-2017/Ms Egypt
Norhan Abdelaleem Ali Kasr Alainy Cairo N30-2017/Ms Egypt
Shady Abo El ela Ismaiel Kasr Alainy Cairo N30-2017/Ms Egypt
Ahmed Abdalla Mohamed AL Ahram Cairo N30-2017/Ms Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdalla ahmed.aboali7268@gmail.com 00201272222923 AL Ahram
City Postal code Country Position/Affiliation
Cairo N30-2017/Ms Egypt Assistant Professor of Anesthesia&ICU and Pain Clinic
Role Name Email Phone Street address
Principal Investigator Hala Mostafa asdasf12.aa@gmail.com 00201225550439 Kasr Alainy
City Postal code Country Position/Affiliation
Cairo N30-2017/Ms Egypt Professor of Anesthesia&ICU and Pain Clinic
Role Name Email Phone Street address
Scientific Enquiries Norhan abd Aleem Ali Nora_satos2009@yahoo.com 00201099941889 Kasr Alainy
City Postal code Country Position/Affiliation
Cairo N30-2017/Ms Egypt Lecturer of Anesthesia&ICU and Pain Clinic
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information