Cerebral Perfusion PressureNCT07482514
Transcranial Doppler and NIRS Monitoring of Cerebral Hemodynamics in Pediatric Laparoscopic Surgery
An observational study of Cerebral Perfusion Pressure and Trendelenburg, run by Hanife Kabukcu at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic surgery has become increasingly common in pediatric patients due to its minimally invasive nature and favorable postoperative outcomes. However, the creation of pneumoperitoneum with carbon dioxide (CO₂) insufflation and the use of the Trendelenburg position may increase intra-abdominal pressure and… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Cerebral Perfusion Pressure, Trendelenburg, Pediatric
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2026to 1 Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 2-10 years who are scheduled for elective pediatric laparoscopic surgery under general anesthesia will be included. Only patients with ASA physical status I-II will be eligible. Patients with known neurological disorders, intracranial pathology, cerebrovascular disease, severe cardiac or respiratory disease, or who develop intraoperative hemodynamic instability will be excluded. Cerebral hemodynamics will be monitored using transcranial Doppler ultrasonography (TCD) and near-infrared spectroscopy (NIRS) at three predefined intraoperative time points. Written informed consent will be obtained from the parent or legal guardian prior to enrollment.
Who may be able to join
- Scheduled for elective laparoscopic inguinal hernia repair
- American Society of Anesthesiologists (ASA) physical status I-II
- Undergoing surgery under general anesthesia
- Written informed consent obtained from parent or legal guardian
Who cannot join
- Intracranial pathology that may increase intracranial pressure
- History of cerebrovascular disease
- Development of intraoperative hemodynamic instability
- Severe cardiac or respiratory disease
- Inability to perform transcranial Doppler measurements
- Parent or legal guardian declines participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Akdeniz University
Antalya, Antalya
Sinem Omca, +905061187398, snmomca@gmail.com
Sinem Omca
About this study
Official title: Evaluation of Cerebral Hemodynamic Changes Using Transcranial Doppler and Near-Infrared Spectroscopy During Pediatric Laparoscopic Surgery
Laparoscopic surgery has become increasingly common in pediatric patients due to its minimally invasive nature and favorable postoperative outcomes. However, the creation of pneumoperitoneum with carbon dioxide (CO₂) insufflation and the use of the Trendelenburg position may increase intra-abdominal pressure and potentially influence intracranial pressure and cerebral hemodynamics. These physiological changes may affect cerebral perfusion and oxygenation during surgery.
This prospective observational study aims to evaluate cerebral hemodynamic changes during pediatric laparoscopic inguinal hernia repair using transcranial Doppler ultrasonography (TCD) and near-infrared spectroscopy (NIRS). Middle cerebral artery (MCA) flow velocities and pulsatility index (PI) will be measured with TCD as indirect indicators of intracranial pressure, and their relationship with cerebral oxygen saturation measured by NIRS will be assessed. In addition, mean arterial pressure and end-tidal CO₂ values will be recorded to evaluate their association with cerebral hemodynamic changes during different phases of surgery.
Read the detailed description
Laparoscopic surgery has become widely adopted in pediatric patients due to its minimally invasive nature, reduced postoperative pain, shorter hospital stay, and improved cosmetic outcomes. Laparoscopic inguinal hernia repair has been increasingly preferred over open techniques because of its potential advantages in surgical visualization and reduced complication rates. However, the establishment of pneumoperitoneum with carbon dioxide (CO₂) insufflation and the use of the Trendelenburg position are essential components of laparoscopic procedures and may lead to significant physiological changes.
The combination of pneumoperitoneum and Trendelenburg positioning can increase intra-abdominal pressure and central venous pressure, potentially resulting in elevated intracranial pressure and alterations in cerebral hemodynamics. These changes may influence cerebral perfusion and oxygenation during anesthesia. Increased intra-abdominal pressure may impair venous return from the brain, while changes in arterial carbon dioxide levels may contribute to cerebral vasodilation and further modify cerebral blood flow.
This prospective observational study aims to evaluate cerebral hemodynamic changes during pediatric laparoscopic inguinal hernia surgery using noninvasive neuromonitoring techniques. Transcranial Doppler ultrasonography (TCD) will be used to measure middle cerebral artery (MCA) flow velocities and pulsatility index (PI) as indirect indicators of intracranial pressure and cerebral blood flow dynamics. Cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS).
Hemodynamic parameters including mean arterial pressure and end-tidal carbon dioxide (EtCO₂) will also be recorded to assess their relationship with cerebral hemodynamic changes.
Measurements will be performed at three predefined time points:
After induction of general anesthesia in the supine position,
Ten minutes after the establishment of pneumoperitoneum and placement in the Trendelenburg position,
Ten minutes before discontinuation of the inhalational anesthetic at the end of surgery.
The primary objective of the study is to evaluate changes in MCA flow velocity and pulsatility index during laparoscopic surgery. The secondary objective is to assess the relationship between cerebral oxygen saturation measured by NIRS and cerebral blood flow parameters obtained from TCD, as well as their association with mean arterial pressure and end-tidal CO₂.
- Conditions
- Cerebral Perfusion Pressure, Trendelenburg, Pediatric
- Keywords
- transcranial doppler usg, cerebral perfusion, trendelenburg, nırs, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Laparoscopic Surgery Patients | Children aged 2-10 years undergoing elective laparoscopic inguinal hernia repair, monitored for cerebral hemodynamics using TCD and NIRS at three predefined intraoperative time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsatility Index (PI)
MCA pulsatility index measured by TCD to evaluate changes in cerebral vascular resistance and intracranial pressure.
Measured: 1-After induction of anesthesia in the supine position 2-10 minutes after pneumoperitoneum and Trendelenburg positioning 3-10 minutes before discontinuation of inhalational anesthetic
Middle Cerebral Artery (MCA) Flow Velocity
MCA peak systolic, end-diastolic, and mean velocities measured using transcranial Doppler (TCD) as an indirect indicator of cerebral perfusion.
Measured: 1-After induction of anesthesia in the supine position 2-10 minutes after pneumoperitoneum and Trendelenburg positioning 3-10 minutes before discontinuation of inhalational anesthetic
Secondary outcomes (1)
Cerebral Oxygen Saturation (rSO₂)
Regional cerebral oxygen saturation measured continuously by near-infrared spectroscopy (NIRS) during surgery.
Measured: 1-After induction of anesthesia in the supine position 2-10 minutes after pneumoperitoneum and Trendelenburg positioning 3-10 minutes before discontinuation of inhalational anesthetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
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 Cerebral Perfusion PressureStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hanife Kabukcu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanife Kabukcu, Akdeniz University
- Investigators
- Hanife Kabukcu, Study director, Akdeniz UniversitySinem Omca, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482514
- Sponsor's protocol ID
- PED-TCD-NIRS-2026
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pelizzo G, Bernardi L, Carlini V, Pasqua N, Mencherini S, Maggio G, De Silvestri A, Bianchi L, Calcaterra V. Laparoscopy in children and its impact on brain oxygenation during routine inguinal hernia repair. J Minim Access Surg. 2017 Jan-Mar;13(1):51-56. doi: 10.4103/0972-9941.181800.
PubMed 27251842Tuna AT, Akkoyun I, Darcin S, Palabiyik O. Effects of carbon dioxide insufflation on regional cerebral oxygenation during laparoscopic surgery in children: a prospective study. Braz J Anesthesiol. 2016 May-Jun;66(3):249-53. doi: 10.1016/j.bjane.2014.10.004. Epub 2015 May 12.
PubMed 27108820
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Hemodynamic Changes Using Transcranial Doppler and Near-Infrared Spectroscopy During Pediatric Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07482514
- Acronym / sponsor ID
- PED-TCD-NIRS-2026
- Conditions
- Cerebral Perfusion Pressure, Trendelenburg, Pediatric
- Keywords
- transcranial doppler usg, cerebral perfusion, trendelenburg, nırs, pediatric
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hanife KabukcuUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 19 Mar 2026 (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.
Laparoscopic surgery has become increasingly common in pediatric patients due to its minimally invasive nature and favorable postoperative outcomes. However, the creation of pneumoperitoneum with carbon dioxide (CO₂) insufflation and the use of the Trendelenburg position may increase intra-abdominal pressure and potentially influence intracranial pressure and cerebral hemodynamics. These physiological changes may affect cerebral perfusion and oxygenation during surgery.
This prospective observational study aims to evaluate cerebral hemodynamic changes during pediatric laparoscopic inguinal hernia repair using transcranial Doppler ultrasonography (TCD) and near-infrared spectroscopy (NIRS). Middle cerebral artery (MCA) flow velocities and pulsatility index (PI) will be measured with TCD as indirect indicators of intracranial pressure, and their relationship with cerebral oxygen saturation measured by NIRS will be assessed. In addition, mean arterial pressure and end-tidal CO₂ values will be recorded to evaluate their association with cerebral hemodynamic changes during different phases of surgery.
Detailed description
Laparoscopic surgery has become widely adopted in pediatric patients due to its minimally invasive nature, reduced postoperative pain, shorter hospital stay, and improved cosmetic outcomes. Laparoscopic inguinal hernia repair has been increasingly preferred over open techniques because of its potential advantages in surgical visualization and reduced complication rates. However, the establishment of pneumoperitoneum with carbon dioxide (CO₂) insufflation and the use of the Trendelenburg position are essential components of laparoscopic procedures and may lead to significant physiological changes.
The combination of pneumoperitoneum and Trendelenburg positioning can increase intra-abdominal pressure and central venous pressure, potentially resulting in elevated intracranial pressure and alterations in cerebral hemodynamics. These changes may influence cerebral perfusion and oxygenation during anesthesia. Increased intra-abdominal pressure may impair venous return from the brain, while changes in arterial carbon dioxide levels may contribute to cerebral vasodilation and further modify cerebral blood flow.
This prospective observational study aims to evaluate cerebral hemodynamic changes during pediatric laparoscopic inguinal hernia surgery using noninvasive neuromonitoring techniques. Transcranial Doppler ultrasonography (TCD) will be used to measure middle cerebral artery (MCA) flow velocities and pulsatility index (PI) as indirect indicators of intracranial pressure and cerebral blood flow dynamics. Cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS).
Hemodynamic parameters including mean arterial pressure and end-tidal carbon dioxide (EtCO₂) will also be recorded to assess their relationship with cerebral hemodynamic changes.
Measurements will be performed at three predefined time points:
After induction of general anesthesia in the supine position,
Ten minutes after the establishment of pneumoperitoneum and placement in the Trendelenburg position,
Ten minutes before discontinuation of the inhalational anesthetic at the end of surgery.
The primary objective of the study is to evaluate changes in MCA flow velocity and pulsatility index during laparoscopic surgery. The secondary objective is to assess the relationship between cerebral oxygen saturation measured by NIRS and cerebral blood flow parameters obtained from TCD, as well as their association with mean arterial pressure and end-tidal CO₂.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Laparoscopic Surgery Patients | – | –Children aged 2-10 years undergoing elective laparoscopic inguinal hernia repair, monitored for cerebral hemodynamics using TCD and NIRS at three predefined intraoperative time points. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 2-10 years who are scheduled for elective pediatric laparoscopic surgery under general anesthesia will be included. Only patients with ASA physical status I-II will be eligible. Patients with known neurological disorders, intracranial pathology, cerebrovascular disease, severe cardiac or respiratory disease, or who develop intraoperative hemodynamic instability will be excluded. Cerebral hemodynamics will be monitored using transcranial Doppler ultrasonography (TCD) and near-infrared spectroscopy (NIRS) at three predefined intraoperative time points. Written informed consent will be obtained from the parent or legal guardian prior to enrollment.
Key inclusion criteria (4 listed)
- Scheduled for elective laparoscopic inguinal hernia repair
- American Society of Anesthesiologists (ASA) physical status I-II
- Undergoing surgery under general anesthesia
- Written informed consent obtained from parent or legal guardian
Key exclusion criteria (6 listed)
- Intracranial pathology that may increase intracranial pressure
- History of cerebrovascular disease
- Development of intraoperative hemodynamic instability
- Severe cardiac or respiratory disease
- Inability to perform transcranial Doppler measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulsatility Index (PI)
Time frame: 1-After induction of anesthesia in the supine position 2-10 minutes after pneumoperitoneum and Trendelenburg positioning 3-10 minutes before discontinuation of inhalational anesthetic
MCA pulsatility index measured by TCD to evaluate changes in cerebral vascular resistance and intracranial pressure.
Middle Cerebral Artery (MCA) Flow Velocity
Time frame: 1-After induction of anesthesia in the supine position 2-10 minutes after pneumoperitoneum and Trendelenburg positioning 3-10 minutes before discontinuation of inhalational anesthetic
MCA peak systolic, end-diastolic, and mean velocities measured using transcranial Doppler (TCD) as an indirect indicator of cerebral perfusion.
1 secondary outcome
Cerebral Oxygen Saturation (rSO₂)
Time frame: 1-After induction of anesthesia in the supine position 2-10 minutes after pneumoperitoneum and Trendelenburg positioning 3-10 minutes before discontinuation of inhalational anesthetic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Results publication: PubMed 27251842Pelizzo G, Bernardi L, Carlini V, Pasqua N, Mencherini S, Maggio G, De Silvestri A, Bianchi L, Calcaterra V. Laparoscopy in children and its impact on brain oxygenation during routine inguinal hernia repair. J Minim Access Surg. 2017 Jan-Mar;13(1):51-56. doi: 10.4103/0972-9941.181800.
- Results publication: PubMed 27108820Tuna AT, Akkoyun I, Darcin S, Palabiyik O. Effects of carbon dioxide insufflation on regional cerebral oxygenation during laparoscopic surgery in children: a prospective study. Braz J Anesthesiol. 2016 May-Jun;66(3):249-53. doi: 10.1016/j.bjane.2014.10.004. Epub 2015 May 12.
- Individual participant dataSharing planned: Yes
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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.
Hanife Kabukcu study director
Akdeniz University
Sinem Omca principal investigator
Akdeniz University
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 Cerebral Perfusion Pressure and Trendelenburg, run by Hanife Kabukcu 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 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: opening soon, as of the sponsor's last update on 19 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanife Kabukcu (+905337319555, hanifekabukcu@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulsatility Index (PI) (time frame: 1-After induction of anesthesia in the supine position 2-10 minutes after pneumoperitoneum and Trendelenburg positioning 3-10 minutes before discontinuation of inhalational anesthetic). The study lists 2 primary outcomes in all. 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 NCT07482514, 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 19 Mar 2026.