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Gallbladder surgery gas pressure may secretly affect brain pressure

NCT ID NCT07162922

Knowledge-focused Sponsor: Engin Çetin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 76 adults having gallbladder surgery to see if the gas pressure used in the belly affects the optic nerve sheath diameter, a non-invasive measure of brain pressure. Patients were randomly assigned to low (8 mmHg) or standard (14 mmHg) pressure. Researchers measured the nerve sheath before, during, and after surgery and also tracked nausea and other symptoms. The goal is to understand if lower pressure might be safer for the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help surgeons choose safer gas pressures during laparoscopic surgery to reduce the risk of hidden brain pressure changes.
What could go wrong
This is a small, completed study measuring a temporary physical change, not a treatment. The link to actual patient symptoms is uncertain, and results may not apply to other surgeries or patients with health issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

76 people

The number who actually took part.

Started

Sep 2025

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

intracranial hypertension Pneumoperitoneum

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Increased intracranial pressure disorders Perioperative complication Pneumoperitoneum

Contacts and locations

Locations

  • University of Health Sciences Kocaeli City Hospital

    Kocaeli, Izmit, 41100, Turkey (Türkiye)

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