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Completed

NCT Number: NCT07264764

Optic Nerve Sheath Diameter and Postoperative Cognitive Disfunction at Laparoscopic Surgery

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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duzce University Medicine School, Anesthesiology and Reanimation Department

Düzce, 81620, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optic nerve sheath diameter (ONSD)

Diagnostic Test

All parameters (ONSD, rSO2, IAP, EtCO2, Ppeak, SBP, DBP, MAP, HR) were recorded at:T0: Pre-induction baseline,T1: 5 min after induction,T2: 5 min after COpneumoperitoneum,T3: 30 min after pneumoperitoneum,T4: 5 min post-desufflation. ONSD was measured using a high-frequency (18 MHz) linear ultrasound probe (Mylab 5, Esaote, Genoa, Italy). The ONSD was defined as the distance between the outer edges of the optic nerve sheath 3 mm posterior to the optic disc. rSO2 was measured continuously using NIRS (INVOS 4100) with bilateral frontal sensors. MMSE, administered in a face-to-face format by a trained researcher on the day before surgery (baseline) and 24 hours postoperatively. A decline of ≥2 points in the postoperative score compared to baseline was considered indicative of postoperative cognitive dysfunction (POCD).

Primary outcomes

  1. 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

  1. postoperative cognitive dysfunction

    Time frame: Time 1: Preoperative one day before Time 2: Postoperative 24 hours

    Cognitive performance was evaluated using the Mini-Mental State Examination (MMSE), administered in a face-to-face format by a trained researcher on the day before surgery (baseline) and 24 hours postoperatively.The Mini Mental State Examination (MMSE) test consists of 11 questions and is evaluated from a minimum score of 0 to a maximum of 30, below 24 point is considered worse outcome, while a decline of ≥2 points in the postoperative score compared to baseline was considered indicative of postoperative cognitive dysfunction (POCD), consistent with prior studies.

  2. cerebral oxygenation

    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

    Regional cerebral oxygen saturation (rSO2) was measured continuously using near-infrared spectroscopy (NIRS; INVOS 4100, Medtronic, Minneapolis, MN, USA) with bilateral frontal sensors.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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