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Completed

NCT Number: NCT07639502

Impact of Reverse Trendelenburg on ONSD in Obesity Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bagcılar Training Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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 including end-tidal carbon dioxide and peak airway pressure, will also be recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) ≥ 40 kg/m² and scheduled for elective laparoscopic bariatric surgery.
  • Ability to provide written informed consent.
  • Willingness to participate in the study and comply with study procedures.

Exclusion criteria

  • Age younger than 18 years or older than 65 years.
  • Refusal or inability to provide written informed consent.
  • History of ophthalmologic disease that may affect optic nerve sheath diameter (ONSD) measurements (e.g., glaucoma, optic neuritis, optic nerve tumors, severe ocular trauma, previous ocular surgery).
  • Known intracranial pathology, including intracranial hypertension, hydrocephalus, intracranial mass lesions, or cerebrovascular disease.
  • Neurological disorders that may influence intracranial pressure measurements.
  • Emergency surgery.
  • Pregnancy.
  • Severe cardiopulmonary disease (e.g., decompensated heart failure, severe pulmonary hypertension, severe chronic obstructive pulmonary disease).
  • Inability to obtain adequate ocular ultrasonography images for ONSD measurement.
  • Conversion from laparoscopic to open surgery. Intraoperative events requiring deviation from the study protocol.

Treatment and study plan

Pre-pneumoperitoneum Reverse Trendelenburg Group

Other

Patients are placed in the reverse Trendelenburg position before carbon dioxide insufflation and establishment of pneumoperitoneum.

Primary outcomes

  1. Change in Optic Nerve Sheath Diameter (ONSD)

    Time frame: Baseline (before induction of anesthesia), immediately after induction, 5 minutes after pneumoperitoneum and positioning, and at the end of surgery.

    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.

Secondary outcomes

  1. Mean Arterial Pressure (MAP)

    Time frame: During the intraoperative period

    Mean arterial pressure measured during surgery

  2. Heart Rate

    Time frame: During the intraoperative period

    Heart rate measured during surgery.

  3. Peak Airway Pressure

    Time frame: During the intraoperative period

    Peak airway pressure measured during surgery

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

Effect of Pre-pneumoperitoneum Reverse Trendelenburg Positioning on Optic Nerve Sheath Diameter During Bariatric Surgery: A Prospective Randomized Controlled Trial

Acronym: ONSD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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