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The Effects of Positive End-expiratory Pressure (PEEP) on Optic Nerve Sheath Diameter in Laparoscopic Cholecystectomy

The Effects of Positive End-Expiratory Pressure (PEEP) on Optic Nerve Sheath Diameter (ONSD) in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia: A Prospective Interventional Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06979999
Acronym
PEEPON
Enrollment
34
Registered
2025-05-20
Start date
2024-05-23
Completion date
2025-12-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure, Mechanical Ventilation, Optic Nerve Sheath Diameter, Positive End-expiratory Pressure (PEEP)

Brief summary

This prospective interventional study will evaluate the effects of applying positive end-expiratory pressure (PEEP) at 10 cmH₂O on optic nerve sheath diameter (ONSD) in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of approximately 40 adult patients (ASA physical status I-II) will be included following informed consent. 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.

Interventions

Application of 10 cmH₂O PEEP during mechanical ventilation after pneumoperitoneum creation in patients undergoing laparoscopic cholecystectomy.

Sponsors

Nigde Omer Halisdemir University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

\- Adult patients (age ≥ 18 years) American Society of Anesthesiologists (ASA) physical status I-III Scheduled for elective laparoscopic cholecystectomy under general anesthesia Signed informed consent

Exclusion criteria

* resence of acute or chronic eye disease 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Optic Nerve Sheath Diameter (ONSD)Intraoperative; T0, T1, T2ONSD will be measured via ultrasound at 3 time points during surgery.

Secondary

MeasureTime frameDescription
Change in Peak Airway Pressure (Ppeak)Intraoperative measurement at T0, T1, and T2Peak airway pressure will be measured using the ventilator settings at three predefined intraoperative time points to evaluate respiratory mechanics during PEEP application.
Change in Dynamic Lung ComplianceIntraoperative measurement at T0, T1, and T2Dynamic lung compliance will be calculated using the formula: Tidal Volume / (Ppeak - PEEP) and measured at three intraoperative time points.
Change in End-Tidal Carbon Dioxide (EtCO₂)Intraoperative measurement at T0, T1, and T2End-tidal CO₂ levels will be recorded intraoperatively to monitor changes in ventilation efficiency during surgery.
Changes in Heart Rate (HR) and Mean Arterial Pressure (MAP) Time FrameIntraoperative measurement at T0, T1, and T2Heart rate and mean arterial pressure will be recorded at predefined time points to assess hemodynamic stability during surgery.
Peripheral Oxygen Saturation (SpO₂)Intraoperative continuous monitoring and recorded at T0, T1, and T2Peripheral oxygen saturation will be monitored continuously and recorded at specified intraoperative time points.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026