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Protective effect of insulin against inhalation anesthesia induced apoptosis in laporoscopic cholecystectomy patients

The Protective Effect of Insulin against Isoflurane or Sevoflurane Induced Hepatocellular Apoptosis in Laparoscopic Cholecystectomy Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000556448
Enrollment
80
Registered
2016-04-29
Start date
2013-02-14
Completion date
2014-02-02
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 chol

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.

Sponsors

Theodor Bilharz Research Institute
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
25 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

Elective laporscopic cholecystectomy. Age: 25-55 years. Gender: Both male and female. BMI: 20-30 kg/m2 (Normal weight). ASA Class: I.

Exclusion criteria

Pregnancy and lactation. Fever or sepsis. Addicts and drug abusers. Acute cholecystitis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026