Postoperative Cognitive DysfunctionNCT07264764
Optic Nerve Sheath Diameter and Postoperative Cognitive Disfunction at Laparoscopic Surgery
An observational study of Postoperative Cognitive Dysfunction, run by Duzce University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Optic nerve sheath diameter (ONSD)
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 May 2021
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: - Aged 20-60 years, ASA I-III, all patients who will undergo upper abdominal surgery without any excluded criteria.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Medicine School, Anesthesiology and Reanimation Department
Düzce, 81620
About this study
Official title: 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.
Read the 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
- Postoperative Cognitive Dysfunction
- Being tested
- Optic nerve sheath diameter (ONSD)
- Keywords
- optic nerve sheath diameter, laparoscopic surgery, postoperative cognitive dysfunction, regional cerebral oxygen saturation
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Optic nerve sheath diameter (ONSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: • 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
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.
Measured: Time 1: Preoperative one day before Time 2: Postoperative 24 hours
cerebral oxygenation
Regional cerebral oxygen saturation (rSO2) was measured continuously using near-infrared spectroscopy (NIRS; INVOS 4100, Medtronic, Minneapolis, MN, USA) with bilateral frontal sensors.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Jul 2020
- Primary completion1 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulbin sezen, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264764
- Sponsor's protocol ID
- DuzceU-GYSezen-005
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31277606Amini 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.
PubMed 22944553Demirgan 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.
PubMed 33089454Jo 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.
PubMed 26885301Keller 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.
PubMed 27815745Aba O, Yalcin Sezen G, Ersoy Karka O. Multimodal perioperative monitoring of intracranial pressure surrogates and cerebral oxygenation during laparoscopic surgery: implications for early cognitive outcomes. BMC Anesthesiol. 2026 Jun 8;26(1):414. doi: 10.1186/s12871-026-03978-7.
PubMed 42260367
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optic Nerve Sheath Diameter, Cerebral Oxygen Saturation and Cognitive Functions in Patients Undergoing Laparoscopic Abdominal Surgeries; Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07264764
- Acronym / sponsor ID
- DuzceU-GYSezen-005
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- optic nerve sheath diameter, laparoscopic surgery, postoperative cognitive dysfunction, regional cerebral oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laparoscopic abdominal surgery | – | Diagnostic Test: Optic nerve sheath diameter (ONSD)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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- - Aged 20-60 years, ASA I-III, all patients who will undergo upper abdominal surgery without any excluded criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- pregnancy,
- known neurological or ocular disease,
- prior ocular surgery,
- significant cardiovascular disease (moderate to severe),
- chronic obstructive pulmonary disease (COPD),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Diagnostic test | laparoscopic abdominal surgery |
Primary outcome
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
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.
2 secondary outcomes
postoperative cognitive dysfunction
Time frame: Time 1: Preoperative one day before Time 2: Postoperative 24 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Background: PubMed 31277606Zhou 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.
- Background: PubMed 22944553Amini 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.
- Background: PubMed 33089454Demirgan 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.
- Results publication: PubMed 26885301Jo 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.
- Results publication: PubMed 27815745Keller 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.
- Derived from this study: PubMed 42260367Aba O, Yalcin Sezen G, Ersoy Karka O. Multimodal perioperative monitoring of intracranial pressure surrogates and cerebral oxygenation during laparoscopic surgery: implications for early cognitive outcomes. BMC Anesthesiol. 2026 Jun 8;26(1):414. doi: 10.1186/s12871-026-03978-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07264764, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.