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IRCT20240718062454N1 IRCT 2024-08-01 Rasht University of Medical Sciences "Investigating Intra-abdominal Pressures on Elderly Patients during Elective Laparoscopic Cholecystectomy" "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" 2024-09-22 anticipated 31 Complete https://irct.ir/trial/78026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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), Blinding description: 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. 3 Condition 1: Intraabdominal pressure. Condition 2: Hemodynamic parameters. Condition 3: cerebral oxygenation. Condition 4: Elective laparoscopic cholecystectomy. Intervention 1: Intervention group: High intra-abdominal pressure (13-15 mmHg). Intervention 2: Intervention group: High intra-abdominal pressure (13-15 mmHg). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Samane Ghazanfar Tehran
Namjoo Street, Rasht
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3336 9823 Tehranisamaneh88rasht@gmail.com Rasht University of Medical Sciences scientific Samaneh Ghazanfar Tehran
رشت، خیابان نامجو، بیمارستان الزهرا، مرکز تحقیقات بیهوشی
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3336 9823 Tehranisamaneh88rasht@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Elderly patients over 60 years old with ASA class 1-2 are candidates for elective laparoscopic cholecystectomy. 60 years no limit Both 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 Treatment - Surgery Treatment - Surgery Intervention group: High intra-abdominal pressure (13-15 mmHg) Intervention group: High intra-abdominal pressure (13-15 mmHg) The amount of brain oxygen of patients. Timepoint: In the awake state (T0), 5 minutes after induction of anesthesia and intubation before Blowing gas into the abdomen (T1) and then 5 minutes after blowing gas into the abdomen (T2), 15 minutes after blowing gas into the abdomen (T3), immediately after gas exit and changing the horizontal position (T5) And it will be recorded 15 minutes after the exit of gas (T6). Method of measurement: It will be measured based on the cerebral oxygenation percentage listed in the patient's monitoring. Systolic, diastolic and mean arterial blood pressure. Timepoint: In the awake state (T0), 5 minutes after induction of anesthesia and intubation before Blowing gas into the abdomen (T1) and then 5 minutes after blowing gas into the abdomen (T2), 15 minutes after blowing gas into the abdomen (T3), immediately after gas exit and changing the horizontal position (T5) And it will be recorded 15 minutes after the exit of gas (T6). Method of measurement: Based on the blood pressure listed in the patient's monitoring, it will be measured in millimeters of mercury. The patient's heart rate. Timepoint: In the awake state (T0), 5 minutes after induction of anesthesia and intubation before blowing gas into the abdomen (T1) and then 5 minutes after blowing gas into the abdomen (T2), 15 minutes after blowing gas into the abdomen Abdomen (T3) will be recorded immediately after passing gas and changing the horizontal position (T5) and 15 minutes after passing gas (T6). Method of measurement: It will be measured based on the number of beats listed in the patient's monitoring based on the number of heart beats per minute. Oxygen saturation of arterial blood of patients. Timepoint: In the awake state (T0), 5 minutes after induction of anesthesia and intubation before blowing gas into the abdomen (T1) and then 5 minutes after blowing gas into the abdomen (T2), 15 minutes after blowing gas into the abdomen Abdomen (T3) will be recorded immediately after passing gas and changing the horizontal position (T5) and 15 minutes after passing gas (T6). Method of measurement: It will be measured based on the arterial oxygenation percentage listed in the patient monitoring. End-expiratory carbon dioxide. Timepoint: In the awake state (T0), 5 minutes after induction of anesthesia and intubation before blowing gas into the abdomen (T1) and then 5 minutes after blowing gas into the abdomen (T2), 15 minutes after blowing gas into the abdomen Abdomen (T3) will be recorded immediately after passing gas and changing the horizontal position (T5) and 15 minutes after passing gas (T6). Method of measurement: Based on the exhaled carbon dioxide listed in the patient's monitoring, it will be measured in millimeters of mercury. Investigation of complications and outcome of patients in recovery in two groups of high intra-abdominal pressure (13-15 mm Hg) and low intra-abdominal pressure (10-12 mm Hg). Timepoint: After surgery. Method of measurement: The presence of nausea, vomiting/hemorrhage/pneumothorax/loss of saturation/increase or decrease in blood pressure will be measured in patients. Satisfaction of the surgeon. Timepoint: After surgery. Method of measurement: Based on the 5-point Likert scale, it will be measured as very poor/poor/satisfactory/good/excellent. Rasht University of Medical Sciences Approved 2024-06-26 Ethics committee of Guilan University of Medical Sciences Anesthesiology Research Center , Alzahra Hospital, Guilan University of Medical Sciences, Namjoo Street, Rasht, Iran Rasht Guilan Iran (Islamic Republic of)