Clinical Trials Directory

Trials / Completed

CompletedNCT07264764

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
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Duzce University · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTOptic nerve sheath diameter (ONSD)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).

Timeline

Start date
2020-07-01
Primary completion
2021-02-01
Completion
2021-05-01
First posted
2025-12-04
Last updated
2025-12-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07264764. Inclusion in this directory is not an endorsement.