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"Investigating Intra-abdominal Pressures on Elderly Patients during Elective Laparoscopic Cholecystectomy"

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240718062454N1
Enrollment
31
Registered
2024-08-01
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Condition 1: Intraabdominal pressure. Condition 2: Hemodynamic parameters. Condition 3: cerebral oxygenation. Condition 4: Elective laparoscopic cholecystectomy.

Interventions

Intervention 1: Intervention group: High intra-abdominal pressure (13-15 mmHg). Intervention 2: Intervention group: High intra-abdominal pressure (13-15 mmHg).

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Elderly patients over 60 years old with ASA class 1-2 are candidates for elective laparoscopic cholecystectomy.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 pa

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamane Ghazanfar Tehran

Rasht University of Medical Sciences

Tehranisamaneh88rasht@gmail.com+98 13 3336 9823

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026