Transcranial Doppler and NIRS Monitoring of Cerebral Hemodynamics in Pediatric Laparoscopic Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-10
SponsorHanife Kabukcu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Intracranial pathology that may increase intracranial pressure
History of cerebrovascular disease
Development of intraoperative hemodynamic instability
Severe cardiac or respiratory disease
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
32 Participants
are grouped into 1 trial groupGroup A: Pediatric Laparoscopic Surgery Patients
Trial outcomes
Primary outcomes
1
Pulsatility Index (PI)
MCA pulsatility index measured by TCD to evaluate changes in cerebral vascular resistance and intracranial pressure.
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 anesthetic2
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.
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 anestheticSecondary outcomes
1
Cerebral Oxygen Saturation (rSO₂)
Regional cerebral oxygen saturation measured continuously by near-infrared spectroscopy (NIRS) during surgery.
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 anestheticSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hanife Kabukcu
Lead sponsor
Akdeniz University
Sponsor institution
Source ClinicalTrials.gov
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