Increased Intracranial Pressure DisordersNCT07162922
Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomy
A study testing 8 mmHg pressure group and 14 mmHg pressure group in people with Increased Intracranial Pressure Disorders and Perioperative Complication, run by Engin Çetin at 1 site in Turkey (Türkiye).
Trial summary
Purpose The goal of this clinical trial is to learn how different intra-abdominal pressures during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which is a non-invasive marker of intracranial pressure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Increased Intracranial Pressure Disorders, Perioperative Complication, Pneumoperitoneum
- What is being tested?
- 8 mmHg pressure group and 14 mmHg pressure group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2025to 21 Dec 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- ASA physical status I-II
- BMI < 30 kg/m²
- Scheduled for elective laparoscopic cholecystectomy
Who cannot join
- Known neurological diseases
- Ocular pathology
- History of elevated intracranial pressure (ICP)
- Pregnancy
- Need for emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kocaeli City Hospital
Kocaeli, Izmit, 41100
About this study
Official title: Impact of Intra-abdominal Pressure on Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Prospective Study
Purpose The goal of this clinical trial is to learn how different intra-abdominal pressures during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which is a non-invasive marker of intracranial pressure. The study will also evaluate whether these changes are related to symptoms such as headache, confusion, and nausea after surgery.
Study Design
Read more
This is a prospective, randomized, double-blind clinical trial. Patients undergoing elective laparoscopic cholecystectomy will be assigned to one of two groups:
Group 1: pneumoperitoneum at 8 mmHg Group 2: pneumoperitoneum at 14 mmHg ONSD will be measured at several time points before, during, and after surgery using transorbital ultrasonography.
Read the detailed description
Purpose The aim of this clinical trial is to investigate how different intra-abdominal pressures applied during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which serves as a reliable, non-invasive marker of intracranial pressure. The study also seeks to determine whether perioperative ONSD changes are associated with postoperative symptoms such as headache, nausea, and disorientation, as well as with recovery parameters and hemodynamic stability.
Study Design
This is a prospective, randomized, double-blind, interventional clinical trial. Eligible patients scheduled for elective laparoscopic cholecystectomy will be randomized into two groups based on pneumoperitoneum pressure:
Group 1 (Low-pressure group): pneumoperitoneum maintained at 8 mmHg Group 2 (High-pressure group): pneumoperitoneum maintained at 14 mmHg
ONSD will be measured via transorbital ultrasonography at standardized perioperative time points:
T0: Before induction of anesthesia
T1: 30 minutes after initiation of pneumoperitoneum
T2: 5 minutes after extubation
T3: 1 hour postoperatively
T4: 2 hours postoperatively
All ultrasonographic assessments will be performed by a trained investigator blinded to the patient's group allocation.
Participation Patients will receive anesthesia and undergo laparoscopic cholecystectomy according to standard surgical protocols.
Each participant will be randomly assigned to one of the two pneumoperitoneum pressure groups (8 mmHg or 14 mmHg).
After surgery, patients will be observed in the recovery unit. Postoperative symptoms including headache, nausea and vomiting will be recorded.
- Being tested
- 8 mmHg pressure group, 14 mmHg pressure group
- Keywords
- optic nerve sheath,, ultrasonography,, cholesistectomy,, pneumoperitoneum
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 mmHg pressure groupOther
Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 8 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
14 mmHg pressure groupOther
Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
| Study group | Role | What they receive |
|---|---|---|
| 8 mmHg pressure group | Active comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 8 mmHg. Receives: Other: 8 mmHg pressure group |
| 14 mmHg pressure group | Active comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg. Receives: Other: 14 mmHg pressure group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Pneumoperitoneum Pressure on ONSD Over Time
To compare the effect of two different pneumoperitoneum pressures (8 mmHg vs. 14 mmHg) on optic nerve sheath diameter (ONSD) during laparoscopic cholecystectomy. ONSD will be assessed by measuring changes with transorbital ultrasonography at multiple perioperative time points
Measured: T0: Before intubation T1: 30 minutes after the initiation of pneumoperitoneum T2: 5 minutes after extubation T3: 1 hour after extubation T4: 2 hours after extubation
Secondary outcomes (3)
Number of participants with postoperative nausea assessed by a standardized 4-point nausea scale
Postoperative nausea will be assessed one hour after surgery using a standardized 4-point scale (0 = no nausea, 1 = mild, 2 = moderate, 3 = severe). The number and proportion of participants with any nausea (score ≥1) will be recorded. Higher scores indicate worse symptoms.
Measured: One hour after surgery
Number of participants with postoperative vomiting within one hour after surgery
Occurrence of vomiting will be recorded during the first postoperative hour. The number and percentage of participants experiencing at least one vomiting episode will be documented (yes/no outcome)
Measured: One hour after surgery
Severity of postoperative headache assessed by Numerical Rating Scale (NRS, 0-10)
Postoperative headache will be evaluated one hour after surgery using a Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst possible pain. Mean NRS scores and the proportion of participants with moderate-to-severe headache (NRS ≥4) will be reported. Higher scores indicate more severe pain.
Measured: One hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start17 Sep 2025
- Primary completion21 Dec 2025
- Study completion21 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Increased Intracranial Pressure DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engin Çetin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Engin Çetin, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162922
- Sponsor's protocol ID
- KSH-ANREA-EC-02
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.
PubMed 28284189Cetin E, Gunel B, Yilmaz M, Ergun A. Dynamic effects of low- and high-pressure pneumoperitoneum on optic nerve sheath diameter during laparoscopic cholecystectomy: a prospective, randomized, observer-blinded clinical trial. BMC Anesthesiol. 2026 Mar 19;26(1):266. doi: 10.1186/s12871-026-03762-7.
PubMed 41851846
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intra-abdominal Pressure on Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07162922
- Acronym / sponsor ID
- KSH-ANREA-EC-02
- Keywords
- optic nerve sheath,, ultrasonography,, cholesistectomy,, pneumoperitoneum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Engin ÇetinOther government
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 21 Dec 2025 (actual)
- First posted
- 9 Sep 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 The goal of this clinical trial is to learn how different intra-abdominal pressures during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which is a non-invasive marker of intracranial pressure. The study will also evaluate whether these changes are related to symptoms such as headache, confusion, and nausea after surgery.
Study Design
This is a prospective, randomized, double-blind clinical trial. Patients undergoing elective laparoscopic cholecystectomy will be assigned to one of two groups:
Group 1: pneumoperitoneum at 8 mmHg Group 2: pneumoperitoneum at 14 mmHg ONSD will be measured at several time points before, during, and after surgery using transorbital ultrasonography.
Detailed description
Purpose The aim of this clinical trial is to investigate how different intra-abdominal pressures applied during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which serves as a reliable, non-invasive marker of intracranial pressure. The study also seeks to determine whether perioperative ONSD changes are associated with postoperative symptoms such as headache, nausea, and disorientation, as well as with recovery parameters and hemodynamic stability.
Study Design
This is a prospective, randomized, double-blind, interventional clinical trial. Eligible patients scheduled for elective laparoscopic cholecystectomy will be randomized into two groups based on pneumoperitoneum pressure:
Group 1 (Low-pressure group): pneumoperitoneum maintained at 8 mmHg Group 2 (High-pressure group): pneumoperitoneum maintained at 14 mmHg
ONSD will be measured via transorbital ultrasonography at standardized perioperative time points:
T0: Before induction of anesthesia
T1: 30 minutes after initiation of pneumoperitoneum
T2: 5 minutes after extubation
T3: 1 hour postoperatively
T4: 2 hours postoperatively
All ultrasonographic assessments will be performed by a trained investigator blinded to the patient's group allocation.
Participation Patients will receive anesthesia and undergo laparoscopic cholecystectomy according to standard surgical protocols.
Each participant will be randomly assigned to one of the two pneumoperitoneum pressure groups (8 mmHg or 14 mmHg).
After surgery, patients will be observed in the recovery unit. Postoperative symptoms including headache, nausea and vomiting will be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| 8 mmHg pressure group | Active comparator | Other: 8 mmHg pressure groupPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 8 mmHg. |
| 14 mmHg pressure group | Active comparator | Other: 14 mmHg pressure groupPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age
- ASA physical status I-II
- BMI < 30 kg/m²
- Scheduled for elective laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- Known neurological diseases
- Ocular pathology
- History of elevated intracranial pressure (ICP)
- Pregnancy
- Need for emergency surgery
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 |
|---|---|---|
| 8 mmHg pressure groupLaparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 8 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. | Other | 8 mmHg pressure group |
| 14 mmHg pressure groupLaparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. | Other | 14 mmHg pressure group |
Primary outcome
Effects of Pneumoperitoneum Pressure on ONSD Over Time
Time frame: T0: Before intubation T1: 30 minutes after the initiation of pneumoperitoneum T2: 5 minutes after extubation T3: 1 hour after extubation T4: 2 hours after extubation
To compare the effect of two different pneumoperitoneum pressures (8 mmHg vs. 14 mmHg) on optic nerve sheath diameter (ONSD) during laparoscopic cholecystectomy. ONSD will be assessed by measuring changes with transorbital ultrasonography at multiple perioperative time points
3 secondary outcomes
Number of participants with postoperative nausea assessed by a standardized 4-point nausea scale
Time frame: One hour after surgery
Number of participants with postoperative vomiting within one hour after surgery
Time frame: One hour after surgery
Severity of postoperative headache assessed by Numerical Rating Scale (NRS, 0-10)
Time frame: One hour after surgery
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 29 Dec 2025.
- Background: PubMed 28284189Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.
- Derived from this study: PubMed 41851846Cetin E, Gunel B, Yilmaz M, Ergun A. Dynamic effects of low- and high-pressure pneumoperitoneum on optic nerve sheath diameter during laparoscopic cholecystectomy: a prospective, randomized, observer-blinded clinical trial. BMC Anesthesiol. 2026 Mar 19;26(1):266. doi: 10.1186/s12871-026-03762-7.
- 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?
A study testing 8 mmHg pressure group and 14 mmHg pressure group in people with Increased Intracranial Pressure Disorders and Perioperative Complication, run by Engin Çetin 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 4 inclusion and 5 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 29 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?
Effects of Pneumoperitoneum Pressure on ONSD Over Time (time frame: T0: Before intubation T1: 30 minutes after the initiation of pneumoperitoneum T2: 5 minutes after extubation T3: 1 hour after extubation T4: 2 hours after extubation). 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 NCT07162922, which also lists 2 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 29 Dec 2025.