The Effects of Positive End-expiratory Pressure (PEEP) on Optic Nerve Sheath Diameter in Laparoscopic Cholecystectomy
NCT ID: NCT06979999
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-29
2025-07-29
Brief Summary
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ONSD will be measured using a high-frequency linear ultrasound probe at three predefined intraoperative time points: (T0) 10 minutes after initiation of mechanical ventilation, (T1) 10 minutes after pneumoperitoneum creation, and (T2) 30 minutes after pneumoperitoneum creation. Dynamic lung compliance, peak airway pressure (Ppeak), end-tidal CO₂ (EtCO₂), heart rate, mean arterial pressure, and SpO₂ will also be recorded.
The aim is to assess whether the application of PEEP influences intracranial pressure indicators, particularly ONSD, during laparoscopic procedures. The study may provide valuable insights into the neurophysiological effects of intra-abdominal pressure and mechanical ventilation strategies in surgical patients.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PEEP Group
This arm includes patients undergoing laparoscopic cholecystectomy under general anesthesia. All participants receive 10 cmH₂O PEEP after pneumoperitoneum creation, and optic nerve sheath diameter (ONSD) is measured intraoperatively at predefined time points.
Positive End-Expiratory Pressure (PEEP)
Application of 10 cmH₂O PEEP during mechanical ventilation after pneumoperitoneum creation in patients undergoing laparoscopic cholecystectomy.
Interventions
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Positive End-Expiratory Pressure (PEEP)
Application of 10 cmH₂O PEEP during mechanical ventilation after pneumoperitoneum creation in patients undergoing laparoscopic cholecystectomy.
Eligibility Criteria
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Inclusion Criteria
American Society of Anesthesiologists (ASA) physical status I-III
Scheduled for elective laparoscopic cholecystectomy under general anesthesia
Signed informed consent
Exclusion Criteria
Uncontrolled hypertension
Asthma or known chronic pulmonary disease
Any neurological disorders
Body mass index (BMI) \> 35 kg/m²
Use of medications known to affect intracranial pressure
Refusal to participate after signing informed consent
18 Years
70 Years
ALL
No
Sponsors
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Nigde Omer Halisdemir University
OTHER
Responsible Party
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Seval KILBASANLI
Asst. Prof.
Locations
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Niğde Training and Research Hospital
Niğde, Niğde Province, Turkey (Türkiye)
Countries
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Facility Contacts
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Other Identifiers
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2024/54
Identifier Type: OTHER
Identifier Source: secondary_id
2024/54
Identifier Type: -
Identifier Source: org_study_id
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