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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2025-07-29

Brief Summary

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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 80 adult patients (ASA physical status I-III) 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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Positive End-Expiratory Pressure (PEEP)

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nigde Omer Halisdemir University

OTHER

Sponsor Role lead

Responsible Party

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Seval KILBASANLI

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Niğde Training and Research Hospital

Niğde, Niğde Province, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Seval Kılbasanlı, Asst. Prof.

Role: primary

090-505-724-63-64

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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