Optic Nerve Sheath Diameter and Postoperative Cognitive Disfunction at Laparoscopic Surgery

NCT07264764 | Completed

• 1 other identifier: DuzceU-GYSezen-005
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Optic nerve sheath diameter (ONSD)

  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.

  • 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

Secondary Outcomes (2)

• 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

Study Arms (1)

laparoscopic abdominal surgery

Fifty adult patients (aged 20-60 years; ASA I-III) scheduled for elective laparoscopic abdominal surgery (e.g., cholecystectomy, appendectomy, hernia repair) under general anesthe-sia were enrolled. All patients underwent standardized anesthetic management. Following preoxygenation with 100% oxygen for 2 minutes, anesthesia induction consisted of intravenous thiopental sodium (5-7 mg·kg-¹), fentanyl (1 µg·kg-¹), rocuronium (0.6 mg·kg-¹), and lidocaine (1 mg·kg-¹). Tracheal intubation was performed by an experienced anesthesiologist, with laryngoscopy duration recorded. Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane in 50% O2/air mixture, using volume-controlled ventilation (tidal volume 6-8 mL·kg-¹, PEEP 5 cmHO2, respiratory rate adjusted to maintain end-tidal CO2 \[EtCO2\] 33-40 mmHg). Hemodynamic variables, and peak inspiratory airway pressure (Ppeak) were continuously recorded.

Diagnostic Test: Optic nerve sheath diameter (ONSD)

Interventions

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).

laparoscopic abdominal surgery

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

\- Aged 20-60 years, ASA I-III, all patients who will undergo upper abdominal surgery without any excluded criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Medicine School, Anesthesiology and Reanimation Department

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (5)

• Zhou J, Li J, Ye T, Zeng Y. Ultrasound measurements versus invasive intracranial pressure measurement method in patients with brain injury: a retrospective study. BMC Med Imaging. 2019 Jul 5;19(1):53. doi: 10.1186/s12880-019-0354-0.

  PMID: 31277606 BACKGROUND

• Amini A, Kariman H, Arhami Dolatabadi A, Hatamabadi HR, Derakhshanfar H, Mansouri B, Safari S, Eqtesadi R. Use of the sonographic diameter of optic nerve sheath to estimate intracranial pressure. Am J Emerg Med. 2013 Jan;31(1):236-9. doi: 10.1016/j.ajem.2012.06.025. Epub 2012 Aug 31.

  PMID: 22944553 BACKGROUND

• Demirgan S, Ozcan FG, Gemici EK, Guneyli HC, Yavuz E, Gulcicek OB, Selcan A. Reverse Trendelenburg position applied prior to pneumoperitoneum prevents excessive increase in optic nerve sheath diameter in laparoscopic cholecystectomy: randomized controlled trial. J Clin Monit Comput. 2021 Feb;35(1):89-99. doi: 10.1007/s10877-020-00608-6. Epub 2020 Oct 21.

  PMID: 33089454 BACKGROUND

• Jo YY, Kim JY, Lee MG, Lee SG, Kwak HJ. Changes in cerebral oxygen saturation and early postoperative cognitive function after laparoscopic gastrectomy: a comparison with conventional open surgery. Korean J Anesthesiol. 2016 Feb;69(1):44-50. doi: 10.4097/kjae.2016.69.1.44. Epub 2016 Jan 28.

  PMID: 26885301 RESULT

• Keller DS, Senagore AJ, Fitch K, Bochner A, Haas EM. A new perspective on the value of minimally invasive colorectal surgery-payer, provider, and patient benefits. Surg Endosc. 2017 Jul;31(7):2846-2853. doi: 10.1007/s00464-016-5295-x. Epub 2016 Nov 4.

  PMID: 27815745 RESULT

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: July 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: May 1, 2021
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)