"Comparison of the Effect of Intrَa-Abdominal Pressure on Hemodynamic Parameters and Cerebral Oxygenation during Elective Laparoscopic Cholecystectomy in Elderly Patients under General Anesthesia ; A Double Blind Clinical Trial Study"

Comparison of the effect of intra-abdominal pressures on hemodynamic parameters and cerebral oxygenation during laparoscopic cholecystectomy surgery in elderly patients under general anesthesia.

Clinical trial, two parallel groups, two blind strains, randomized, on 31 patients in each group, to generate a random sequence in this clinical trial, WinPepi software and allocation concealment method will be used.

The study will be conducted in the Razi Teaching Hospital in Rasht. Patients are randomly divided into two groups: high intra-abdominal pressure (13-15 liters per minute) and low intra-abdominal pressure (10-12 liters per minute). Two groups are compared. The surgeon and the anesthesiologist who is responsible for the evaluation and data collection will be unaware of the intra-abdominal pressure applied to the patient.

Inclusion criteria: elderly patients over 60 years old with ASA class 1-2 candidates for elective laparoscopic cholecystectomy Exclusion criteria: patients with cerebrovascular disease (cerebral ischemia or hematoma), neurological disorders (dementia, seizures, Parkinson's and Alzheimer's), uncontrolled hypertension and diabetes, advanced organ failure (class 3 and 4 heart failure), patient refusal to participate in the study Body mass index above 35 and below 18

high intra-abdominal pressure (13-15 mm Hg) ;low intra-abdominal pressure (10-12 mm Hg).

Cerebral oxygenation percentage; systolic, diastolic and mean arterial blood pressure; heart rate; Oxygen saturation of arterial blood; carbon dioxide at the end of exhalation

Patients are assigned to two groups of high intra-abdominal pressure (13-15 mm Hg) and low intra-abdominal pressure (10-12 mm Hg) using the random sequence created in blocks of four by WinPepi software. Allocation concealment will be used for concealment. This method is used to implement the random sequence of participants in the study. So that before assigning the individual, the assigned group is not specified. In this method, using identical sealed envelopes, with a random sequence, in this method, each of the random sequences created is recorded on a card, and the cards are placed inside the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. At the time of placement of eligible patients for the study on the bed of the operating room, one of the envelopes is opened by the surgical technician responsible for adjusting the pressure of the laparoscope and placed in one of the two groups of high and low intra-abdominal pressure based on the pressure recorded in the patient card. Patients will be randomized with the help of four random blocks created by the computer (Win Pepi 11.65 software) by an experienced surgical technician who is not a collaborator of the project through the list of eligible patients who have given informed consent and the sequence of randomization blocks to 1:1 ratio are assigned to one of the two groups of high intra-abdominal pressure (13-15 mm Hg) and low intra-abdominal pressure (10-12 mm Hg).

This study is double-blind. The surgeon and the anesthesiologist, who is responsible for evaluating and collecting data, will be unaware of the intra-abdominal pressure applied to the patient, and the adjustment of the intra-abdominal pressure will be performed by an experienced surgical technician who is not a member of the project. . The anesthesiologist in charge of the patient will be informed about the treatment groups in order to take the necessary measures in case of complications. In order to blind the surgeon, the intra-abdominal pressure monitor of the laparoscope device is placed outside the view of the surgeon and exposed to the view of the surgical technician responsible for adjusting the patient's intra-abdominal pressure.