The Effect Of Low-Flow And Hıgh-Flow Anesthesıa On Intracranıal Pressure (NCT07514026) | Clinical Trial Compass
CompletedNot Applicable
The Effect Of Low-Flow And Hıgh-Flow Anesthesıa On Intracranıal Pressure
Turkey (Türkiye)64 participantsStarted 2024-01-01
Plain-language summary
This prospective randomized study was conducted to evaluate the effects of low-flow and high-flow anesthesia on intracranial dynamics and cerebral oxygenation in patients undergoing laparoscopic hysterectomy in the Trendelenburg position. Intracranial pressure was assessed noninvasively using optic nerve sheath diameter (ONSD), and cerebral oxygenation was monitored using near-infrared spectroscopy (NIRS). Changes in these parameters were assessed under standardized pneumoperitoneum and positioning conditions, and comparisons between anesthesia flow groups were performed according to the predefined study protocol.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Female patients aged 18-75 years
* Scheduled for elective laparoscopic hysterectomy
* American Society of Anesthesiologists (ASA) physical status I-II
* Ability to provide written informed consent
Exclusion Criteria
* Septicemia
* Risk of malignant hyperthermia
* Uncontrolled diabetes mellitus
* Chronic alcohol use
* Prolonged fasting
* Body mass index (BMI) \> 40 kg/m²
* Intracranial space-occupying lesions (e.g., tumors, metastases, abscesses, hematomas, aneurysms)
* History of head trauma or cerebrovascular stroke within the preceding six months
* Known heart failure
* Diagnosis of glaucoma
* Prior carotid surgery or carotid artery stenosis
* ASA physical status ≥ III
* Requirement for massive blood transfusion
* Conversion from volume-controlled to pressure-controlled mechanical ventilation during surgery
* Intraoperative conversion to open surgery
* Patient refusal to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.