- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07264764
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Düzce, Turkey (Türkiye), 81620
- Duzce University Medicine School, Anesthesiology and Reanimation Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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• 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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Regional cerebral oxygen saturation (rSO2) was measured continuously using near-infrared spectroscopy (NIRS; INVOS 4100, Medtronic, Minneapolis, MN, USA) with bilateral frontal sensors.
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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
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postoperative cognitive dysfunction
Time Frame: Time 1: Preoperative one day before Time 2: Postoperative 24 hours
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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.
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Time 1: Preoperative one day before Time 2: Postoperative 24 hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DuzceU-GYSezen-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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