Skip to main content
Clinical Trials/NCT07264764
NCT07264764CompletedNot Applicable

Evaluation of Optic Nerve Sheath Diameter, Cerebral Oxygen Saturation and Cognitive Functions in Patients Undergoing Laparoscopic Abdominal Surgeries; Prospective Observational Study

Duzce University1 site in 1 country50 target enrollmentStarted: July 1, 2020Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Optic nerve sheath diameter (ONSD)

Study Overview

Brief Summary

Purpose:

Pneumoperitoneum during laparoscopic abdominal surgery increases intra-abdominal pressure (IAP), potentially altering intracranial pressure (ICP) and cerebral oxygenation, with unclear implications for early postoperative cognitive dysfunction (POCD). Optic nerve sheath diameter (ONSD) via ultrasonography and near-infrared spectroscopy (NIRS) based cerebral oximetry offer non-invasive monitoring tools to assess these changes.

Detailed Description

In this prospective observational study, fifty ASA I-III patients (20-60 years) undergoing elective laparoscopic abdominal surgery under general anesthesia were enrolled. Serial measurements of bilateral ONSD and regional cerebral oxygen saturation (rSO2, NIRS) were obtained at five perioperative time points: before induction (T0), 5 minutes post-induction (T1), 5 minutes after CO2 pneumoperitoneum (T2), 30 minutes after pneumoperitoneum (T3), and 5 minutes post-desufflation (T4). IAP was measured both intravesically and via insufflator readings. Cognitive function was assessed using the Mini-Mental State Examination (MMSE) preoperatively and at 24 hours postoperatively. Hemodynamic parameters and airway pressures were recorded concurrently.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged 20-60 years;
  • American Society of Anesthesiologists [ASA] I-III)
  • scheduled for elective laparoscopic abdominal surgery (e.g., cholecystectomy, appendectomy, hernia repair) under general anesthesia

Exclusion Criteria

  • pregnancy,
  • known neurological or ocular disease,
  • prior ocular surgery,
  • significant cardiovascular disease (moderate to severe),
  • chronic obstructive pulmonary disease (COPD),
  • conversion from laparoscopy to open laparo-tomy.

Outcomes

Primary Outcomes

Optic nerve sheath diameter (ONSD)

Time Frame: • T0: Pre-induction baseline • T1: 5 minutes after induction • T2: 5 minutes after CO pneumoperitoneum • T3: 30 minutes after pneumoperitoneum • T4: 5 minutes post-desufflation

ONSD was measured by a single trained anesthesiologist using a high-frequency (18 MHz) linear ultrasound probe (Mylab 5, Esaote, Genoa, Italy). With patients in the supine position and eyelids closed, the probe was gently placed on the upper eyelid in horizontal and vertical planes without exerting pressure. The ONSD was defined as the distance between the outer edges of the optic nerve sheath 3 mm posterior to the optic disc.

Secondary Outcomes

  • postoperative cognitive dysfunction(Time 1: Preoperative one day before Time 2: Postoperative 24 hours)
  • cerebral oxygenation(T0: Pre-induction baseline • T1: 5 minutes after induction • T2: 5 minutes after CO pneumoperitoneum • T3: 30 minutes after pneumoperitoneum • T4: 5 minutes post-desufflation)

Investigators

Sponsor
Duzce University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

gulbin sezen

professor

Duzce University

Study Sites (1)

Loading locations...

Similar Trials

Optic Nerve Sheath Diameter and... | Clinical Trial