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Trial registered on ANZCTR


Registration number
ACTRN12616000556448
Ethics application status
Approved
Date submitted
7/12/2015
Date registered
29/04/2016
Date last updated
29/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protective effect of insulin against inhalation anesthesia induced apoptosis in laporoscopic cholecystectomy patients
Scientific title
The Protective Effect of Insulin against Isoflurane or Sevoflurane Induced Hepatocellular Apoptosis in Laparoscopic Cholecystectomy Patients
Secondary ID [1] 288083 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
apoptosis in laporoscopic cholecystectomy 296950 0
Condition category
Condition code
Anaesthesiology 297193 297193 0 0
Anaesthetics
Oral and Gastrointestinal 297572 297572 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
80 patients undergoing laporoscopic cholecystectomy will be divide into 2 groups. After induction of general anesthesia with propofol 1mg kg-1 , fentanyl 2 microg kg-1 and atracurium 0.5 mg kg-1 then anesthesia will be maintained by: Arm 1 will receive isoflurane inhalational anesthetic by the dose 1.2% (1MAC) and Arm 2 sevoflurane inhalational anesthetic by the dose 2% (1MAC) after induction for maintenance of general anesthesia till the end of surgery. The type of surgery is laporoscopic cholecystectomy which lasts about one hour in our institute. Both inhalational anesthetic drugs will be monitored with infrared gas spectrophotometry to adjust the targeted end tidal concentration. Both arms will be subdivided into control subgroup which will receive 500 ml ringer acetate intravenous infusion 1 hour before surgery, and insulin subgroup which will receive glucose insulin potassium (GIK) intravenous infusion to study its protective effect against apoptosis. GIK is composed of 500 ml of 10% dextrose, 10 mEq of potassium and 10 IU of regular insulin. All fluids will be infused over 30 minutes and will be finished before starting the operation.
Intervention code [1] 293394 0
Treatment: Drugs
Comparator / control treatment
Patients undergoing laporoscopic cholecystectomy will be divided into 2 control groups. Arm 1 will recieve isoflurane inhalational anesthetic and Arm 2 sevoflurane inhalational anesthetic for maintenance of general anesthesia. Both groups will receive regular intravenous fluids solution (ringer acetate) with no drugs at a rate of 3ml kg-1h-1 and will be finished before starting the operation.
Control group
Placebo

Outcomes
Primary outcome [1] 296797 0
Apoptosis assessed by liver biopsy taken for immunohistochemical evaluation of hepatocyte apoptotic biomarkers (Bcl-xl, Akt, Fas, Fas-L, caspase-3,-7and-9) activity.
Timepoint [1] 296797 0
At the end of surgery before the umbilical port closure for all patients.
Primary outcome [2] 296798 0
apoptosis assessed by the following apoptotic biomarkers (Bcl-xl, Akt, Fas, FasL, annexinV, caspase-3,-7 and -9) in the blood.
Timepoint [2] 296798 0
3 ml of venous blood were collected two hours preoperatively (T0), at the end of surgery (T1) and one day after surgery (T24)
Secondary outcome [1] 319379 0
liver function tests (ALT, AST, albumin, bilirubin (Total)), kidney function tests (blood urea and creatinine)
Timepoint [1] 319379 0
2 ml of venous blood were collected 2 hrs before surgery (T0) and 24 Hrs postoperatively (T24)

Eligibility
Key inclusion criteria
Elective laporscopic cholecystectomy.
Age: 25-55 years.
Gender: Both male and female.
BMI: 20-30 kg/m2 (Normal weight).
ASA Class: I.
Minimum age
25 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy and lactation.
Fever or sepsis.
Addicts and drug abusers.
Acute cholecystitis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7396 0
Egypt
State/province [1] 7396 0
Giza

Funding & Sponsors
Funding source category [1] 292511 0
Hospital
Name [1] 292511 0
Theodor Bilharz Research Institute
Address [1] 292511 0
El-Nile St., Warrak El-Hader, Imbaba Giza , Egypt P.O.BOX : 30 Imbaba
Country [1] 292511 0
Egypt
Primary sponsor type
Hospital
Name
Theodor Bilharz Research Institute
Address
El-Nile St., Warrak El-Hader, Imbaba Giza , Egypt P.O.BOX : 30 Imbaba
Country
Egypt
Secondary sponsor category [1] 291220 0
Government body
Name [1] 291220 0
Academy of scientific research and technology
Address [1] 291220 0
101 Kasr El Ainy St. Kasr El Ainy
Cairo 11516
Country [1] 291220 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293988 0
Institutional Review Board of Theodor Bilharz Research Institute (TBRI - IRB)
Ethics committee address [1] 293988 0
Theodor Bilharz Research Institute El Nile St. Warrak ElHadar P.O. Box 30 Imbaba Giza, 12411 Egypt
Ethics committee country [1] 293988 0
Egypt
Date submitted for ethics approval [1] 293988 0
02/01/2013
Approval date [1] 293988 0
11/02/2013
Ethics approval number [1] 293988 0
FWA00010609

Summary
Brief summary
The hypothesis to be studied is that the commonly used inhaled anesthetics isoflurane and sevoflurane may induce apoptosis in liver and insulin can guard against their apoptotic effect. This study has two objectives:
The first one is to compare the apoptotic effect of isoflurane and sevoflurane on human hepatocytes and the second objective is to figure out the rule of insulin infusion as antiapoptoic agent in modulation of such effect evidenced by immunohistochemical study of liver biopsy and blood markers. Pre and postoperative liver and kidney function tests will be measured to help correlating the apoptotic changes with biochemical changes if present.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 663 663 0 0

Contacts
Principal investigator
Name 62006 0
Prof Khalda Galal Radwan
Address 62006 0
Theodor Bilharz Research Institute El Nile St. Warrak ElHadar P.O. Box 30 Imbaba Giza, 12411 Egypt
Country 62006 0
Egypt
Phone 62006 0
+201220411852
Fax 62006 0
Email 62006 0
khalda.radwan31@gmail.com
Contact person for public queries
Name 62007 0
Dr Mohamed A. Maher
Address 62007 0
Theodor Bilharz Research Institute El Nile St. Warrak ElHadar P.O. Box 30 Imbaba Giza, 12411 Egypt
Country 62007 0
Egypt
Phone 62007 0
+201005097625
Fax 62007 0
Email 62007 0
d.mmaher@yahoo.com
Contact person for scientific queries
Name 62008 0
Dr Mohamed A.Maher
Address 62008 0
Theodor Bilharz Research Institute El Nile St. Warrak ElHadar P.O. Box 30 Imbaba Giza, 12411 Egypt
Country 62008 0
Egypt
Phone 62008 0
+201005097625
Fax 62008 0
Email 62008 0
d.mmaher@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary