Transcranial Doppler and NIRS Monitoring of Cerebral Hemodynamics in Pediatric Laparoscopic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Perfusion Pressure, Trendelenburg, Pediatric. Basic parameters: 2 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Cerebral Hemodynamic Changes Using Transcranial Doppler and Near-Infrared Spectroscopy During Pediatric Laparoscopic Surgery
Overview
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.
Primary outcome measures
- 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]
- 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]
Secondary outcome measures (1)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 1 center
- Akdeniz University — Antalya
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. PMID 27251842
- 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. PMID 27108820
Identifiers
NCT: NCT07482514 · PED-TCD-NIRS-2026