- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482514
Transcranial Doppler and NIRS Monitoring of Cerebral Hemodynamics in Pediatric Laparoscopic Surgery
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hanife Kabukcu
- Phone Number: +905337319555
- Email: hanifekabukcu@akdeniz.edu.tr
Study Contact Backup
- Name: Sinem Omca
- Phone Number: +905061187398
- Email: snmomca@gmail.com
Study Locations
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Antalya
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Antalya, Antalya, Turkey (Türkiye)
- Akdeniz University
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Contact:
- Sinem Omca
- Phone Number: +905061187398
- Email: snmomca@gmail.com
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Principal Investigator:
- Sinem Omca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: -Children aged 2-10 years
- 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
Exclusion Criteria:-Known neurological disorders
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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MCA pulsatility index measured by TCD to evaluate changes in cerebral vascular resistance and intracranial pressure.
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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
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-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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Regional cerebral oxygen saturation measured continuously by near-infrared spectroscopy (NIRS) during surgery.
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hanife Kabukcu, Akdeniz University
- Principal Investigator: Sinem Omca, Akdeniz University
Publications and helpful links
General 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.
- Tuna 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PED-TCD-NIRS-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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