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NCT Number: NCT07162922

Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomy

Purpose The goal of this clinical trial is to learn how different intra-abdominal pressures during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which is a non-invasive marker of intracranial pressure. The study will also evaluate whether these changes are related to symptoms such as headache, confusion, and nausea after surgery.

Study Design

This is a prospective, randomized, double-blind clinical trial. Patients undergoing elective laparoscopic cholecystectomy will be assigned to one of two groups:

Group 1: pneumoperitoneum at 8 mmHg Group 2: pneumoperitoneum at 14 mmHg ONSD will be measured at several time points before, during, and after surgery using transorbital ultrasonography.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

About this study

Purpose The aim of this clinical trial is to investigate how different intra-abdominal pressures applied during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which serves as a reliable, non-invasive marker of intracranial pressure. The study also seeks to determine whether perioperative ONSD changes are associated with postoperative symptoms such as headache, nausea, and disorientation, as well as with recovery parameters and hemodynamic stability.

Study Design

This is a prospective, randomized, double-blind, interventional clinical trial. Eligible patients scheduled for elective laparoscopic cholecystectomy will be randomized into two groups based on pneumoperitoneum pressure:

Group 1 (Low-pressure group): pneumoperitoneum maintained at 8 mmHg Group 2 (High-pressure group): pneumoperitoneum maintained at 14 mmHg

ONSD will be measured via transorbital ultrasonography at standardized perioperative time points:

T0: Before induction of anesthesia

T1: 30 minutes after initiation of pneumoperitoneum

T2: 5 minutes after extubation

T3: 1 hour postoperatively

T4: 2 hours postoperatively

All ultrasonographic assessments will be performed by a trained investigator blinded to the patient's group allocation.

Participation Patients will receive anesthesia and undergo laparoscopic cholecystectomy according to standard surgical protocols.

Each participant will be randomly assigned to one of the two pneumoperitoneum pressure groups (8 mmHg or 14 mmHg).

After surgery, patients will be observed in the recovery unit. Postoperative symptoms including headache, nausea and vomiting will be recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-65 years of age
  • ASA physical status I-II
  • BMI < 30 kg/m²
  • Scheduled for elective laparoscopic cholecystectomy

Exclusion criteria

  • Known neurological diseases
  • Ocular pathology
  • History of elevated intracranial pressure (ICP)
  • Pregnancy
  • Need for emergency surgery

Treatment and study plan

8 mmHg pressure group

Other

Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 8 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

14 mmHg pressure group

Other

Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

Primary outcomes

  1. Effects of Pneumoperitoneum Pressure on ONSD Over Time

    Time frame: T0: Before intubation T1: 30 minutes after the initiation of pneumoperitoneum T2: 5 minutes after extubation T3: 1 hour after extubation T4: 2 hours after extubation

    To compare the effect of two different pneumoperitoneum pressures (8 mmHg vs. 14 mmHg) on optic nerve sheath diameter (ONSD) during laparoscopic cholecystectomy. ONSD will be assessed by measuring changes with transorbital ultrasonography at multiple perioperative time points

Secondary outcomes

  1. Number of participants with postoperative nausea assessed by a standardized 4-point nausea scale

    Time frame: One hour after surgery

    Postoperative nausea will be assessed one hour after surgery using a standardized 4-point scale (0 = no nausea, 1 = mild, 2 = moderate, 3 = severe). The number and proportion of participants with any nausea (score ≥1) will be recorded. Higher scores indicate worse symptoms.

  2. Number of participants with postoperative vomiting within one hour after surgery

    Time frame: One hour after surgery

    Occurrence of vomiting will be recorded during the first postoperative hour. The number and percentage of participants experiencing at least one vomiting episode will be documented (yes/no outcome)

  3. Severity of postoperative headache assessed by Numerical Rating Scale (NRS, 0-10)

    Time frame: One hour after surgery

    Postoperative headache will be evaluated one hour after surgery using a Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst possible pain. Mean NRS scores and the proportion of participants with moderate-to-severe headache (NRS ≥4) will be reported. Higher scores indicate more severe pain.

Sponsors and collaborators

Lead sponsor

Engin Çetin

Other Gov

Registry information

Official study title

Impact of Intra-abdominal Pressure on Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Prospective Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Dec 29, 2025

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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