Investigating the effect of administration of insulin glucose solution in the preanhepatic phase on the heart outcome of patients undergoing orthotopic liver transplantation

Investigating the effect of insulin glucose solution administration in the preanhepatic phase of liver transplant patients

A clinical trial with control group, parallel-group, double-blind, phase 3 on 70 patients. The site sealedenvelope is used for randomization

This study will be conducted in Taleghani Hospital, Tehran, on patients undergoing liver transplantation. The patients will be randomly divided into two groups. After standard monitoring, all patients undergo induction with 2-5 mcg/kg fentanyl, 1-2 mg/kg propofol, 1 mg/kg lidocaine and 0.2 mg/kg cis-atracurium. In the preanhepatic stage, the intervention group will receive 500 cc of 5% dextrose along with 10 units of insulin during the first hour after induction, and the control group will receive only 500 cc of normal saline. Dynamic parameters will be recorded using Lidco in all three phases at intervals of every 5 minutes. Blood glucose and blood potassium levels and blood gas tests are performed every one hour. In case of potassium less than 2.5 and hemodynamic disturbance or new arrhythmia appears, KCL infusion of 20 milliequivalents in 200 cc of normal saline will be prescribed within one hour. .

Inclusion criteria: patients undergoing liver transplantation in the preanhepatic stage. Exclusion criteria: diabetes, potassium less than 3 and patients who die within the first 24 hours after transplantation.

. The intervention group will receive 500 cc of 5% dextrose along with 10 units of insulin during the first hour after induction, and the control group will receive only 500 cc of normal saline.

Post-operative complications including tracheal extubation, length of stay in ICU and in the hospital, liver and kidney disorders, infection, incidence of liver re-transplantation and mortality rate.

Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block, two, four or six patients will be included in the study order. Random allocation of blocks of patients into two treatment groups receiving 500 cc of dextrose 5% along with 10 units of insulin and receiving 500 cc of normal saline will be done through Sealed Envelope online software. By referring to https://www.sealedenvelope.com/simple-randomiser/v1/lists by specifying the total number of samples, the number of possible samples in each randomized block (2, 4 and 6 patients) randomization by online software is done For example, like the following output: block identifier block size sequence within block treatment 1 2 1 Group B 1 2 2 Group A 2 4 1 Group A 2 4 2 Group B 2 4 3 Group B 2 4 4 Group A 3 2 1 Group A 3 2 2 Group B ... which is the block number, the number of patients in the block, and the random assignment of each patient (with the corresponding number) to the treatment group. The randomized list of blocks is placed in sealed envelopes and will be provided to the doctor on a daily basis.

The participants do not know which treatment group they are in. Also, to prevent exploitation, the researcher investigating the results is unaware of the allocation of the groups.

Confidentiality and privacy

Study protocol, statistical analysis map, study design, clinical study report will be available

after publishing the paper

Researchers, medical students and anesthesia, professors

If used for future research and in compliance with the principles of referencing

corresponding author Dr. Mohammadreza Moshari rmoshari@yahoo.com

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