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This prospective randomized controlled trial aims to investigate the effect of reverse Trendelenburg positioning applied before pneumoperitoneum on optic nerve sheath diameter (ONSD) and, consequently, intracranial pressure during laparoscopic bariatric surgery. Patients will be randomly assigned to two groups, and perioperative changes in ONSD will be compared between the groups. The primary hypothesis of the study is that applying the reverse Trendelenburg position before pneumoperitoneum may attenuate ONSD enlargement and thereby help prevent increases in intracranial pressure.
Obesity is associated with physiological alterations that may affect intracranial dynamics during laparoscopic surgery. In bariatric procedures, the creation of pneumoperitoneum and the use of reverse Trendelenburg positioning are essential for optimal surgical exposure. However, pneumoperitoneum increases intra-abdominal pressure and may impair venous return from the brain, potentially leading to elevations in intracranial pressure (ICP). These effects may be particularly relevant in obese patients, who are more susceptible to hemodynamic and respiratory changes during surgery.
Direct measurement of ICP using intraventricular or intraparenchymal catheters remains the gold standard; however, these invasive techniques are not feasible in routine surgical practice because of the risks of hemorrhage, infection, and other complications. Ultrasonographic measurement of optic nerve sheath diameter (ONSD) has emerged as a reliable, noninvasive surrogate marker for assessing changes in ICP and has been widely used in perioperative and critical care settings.
Previous studies have demonstrated that pneumoperitoneum may increase ONSD during laparoscopic procedures. Reverse Trendelenburg positioning has been shown to facilitate cerebral venous drainage and may attenuate increases in intracranial pressure. However, the effect of the timing of reverse Trendelenburg positioning relative to pneumoperitoneum creation has not been adequately investigated, particularly in patients undergoing bariatric surgery.
This prospective randomized controlled trial aims to evaluate whether applying the reverse Trendelenburg position before pneumoperitoneum can reduce perioperative increases in ONSD during laparoscopic bariatric surgery. Eligible patients undergoing elective laparoscopic bariatric surgery will be randomly assigned to one of two groups. In the conventional group, pneumoperitoneum will be established before reverse Trendelenburg positioning. In the intervention group, reverse Trendelenburg positioning will be applied before pneumoperitoneum creation.
ONSD measurements will be performed using ocular ultrasonography at predefined perioperative time points. Hemodynamic parameters, including mean arterial pressure and heart rate, as well as respiratory variables such as end-tidal carbon dioxide, peak airway pressure, and dynamic lung compliance, will also be recorded. Postoperative outcomes, including nausea, vomiting, and other perioperative complications, will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-pneumoperitoneum Reverse Trendelenburg Group | Active Comparator | Reverse Trendelenburg positioning is applied before pneumoperitoneum creation. |
|
| Conventional Positioning Group | No Intervention | Pneumoperitoneum is established in the supine position before reverse Trendelenburg positioning. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-pneumoperitoneum Reverse Trendelenburg Group | Other | Patients are placed in the reverse Trendelenburg position before carbon dioxide insufflation and establishment of pneumoperitoneum. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Optic Nerve Sheath Diameter (ONSD) | Optic nerve sheath diameter will be measured ultrasonographically at predefined perioperative time points. The outcome measure is the change in ONSD from baseline and the difference between study groups. | Baseline (before induction of anesthesia), immediately after induction, 5 minutes after pneumoperitoneum and positioning, and at the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure (MAP) | Mean arterial pressure measured during surgery | During the intraoperative period |
| Heart Rate | Heart rate measured during surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SEZEN KUMAS SOLAK, MD | Bagcılar Training Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bagcılar Training Research Hospital | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Participants will be randomly assigned to one of two parallel groups. In the conventional group, pneumoperitoneum will be established in the supine position, followed by placement in the reverse Trendelenburg position. In the intervention group, patients will first be placed in the reverse Trendelenburg position before pneumoperitoneum creation. Perioperative optic nerve sheath diameter (ONSD), hemodynamic variables, respiratory parameters, and postoperative outcomes will be compared between the two groups to evaluate the effect of pre-pneumoperitoneum reverse Trendelenburg positioning on intracranial pressure during laparoscopic bariatric surgery.
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| During the intraoperative period |
| Peak Airway Pressure | End-tidal carbon dioxide levels measured during surgery. | During the intraoperative period |
| Incidence of Postoperative Nausea and Vomiting (PONV) | Percentage of participants experiencing nausea and/or vomiting within the first 24 hours after surgery. | First 24 hours after surgery |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |