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Optic Nerve Sheath Diameter and Postoperative Cognitive Disfunction at Laparoscopic Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07264764
Enrollment
50
Registered
2025-12-04
Start date
2020-07-01
Completion date
2021-05-01
Last updated
2025-12-11

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

Conditions

Postoperative Cognitive Dysfunction

Keywords

optic nerve sheath diameter, laparoscopic surgery, postoperative cognitive dysfunction, regional cerebral oxygen saturation

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.

Interventions

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).

Sponsors

Duzce University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter (ONSD)• T0: Pre-induction baseline • T1: 5 minutes after induction • T2: 5 minutes after CO pneumoperitoneum • T3: 30 minutes after pneumoperitoneum • T4: 5 minutes post-desufflationONSD 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

MeasureTime frameDescription
postoperative cognitive dysfunctionTime 1: Preoperative one day before Time 2: Postoperative 24 hoursCognitive 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.
cerebral oxygenationT0: Pre-induction baseline • T1: 5 minutes after induction • T2: 5 minutes after CO pneumoperitoneum • T3: 30 minutes after pneumoperitoneum • T4: 5 minutes post-desufflationRegional cerebral oxygen saturation (rSO2) was measured continuously using near-infrared spectroscopy (NIRS; INVOS 4100, Medtronic, Minneapolis, MN, USA) with bilateral frontal sensors.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026