Optic Nerve Sheath Diameter and Postoperative Cognitive Disfunction at Laparoscopic Surgery

NCT ID: NCT07264764

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-05-01

Brief Summary

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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

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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

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Postoperative Cognitive Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Optic nerve sheath diameter (ONSD)

Intervention Type 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).

Interventions

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Optic 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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duzce University

OTHER

Sponsor Role lead

Responsible Party

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gulbin sezen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Duzce University Medicine School, Anesthesiology and Reanimation Department

Düzce, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31277606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22944553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33089454 (View on PubMed)

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.

Reference Type RESULT
PMID: 26885301 (View on PubMed)

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.

Reference Type RESULT
PMID: 27815745 (View on PubMed)

Other Identifiers

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DuzceU-GYSezen-005

Identifier Type: -

Identifier Source: org_study_id

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