Transcranial Doppler and NIRS Monitoring of Cerebral Hemodynamics in Pediatric Laparoscopic Surgery

NCT07482514 | Not Yet Recruiting

• 1 other identifier: PED-TCD-NIRS-2026
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cerebral Perfusion Pressure; Trendelenburg; Pediatric

Keywords

transcranial doppler usg; cerebral perfusion; trendelenburg; nırs; pediatric

Outcome Measures

Primary Outcomes (2)

• Pulsatility Index (PI)

  MCA pulsatility index measured by TCD to evaluate changes in cerebral vascular resistance and intracranial pressure.

  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.

  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)

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanife Kabukcu: lead

Study Sites (1)

Akdeniz University

Antalya, Antalya, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• 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 RESULT

Study Officials

• Hanife Kabukcu

  Akdeniz University

  STUDY DIRECTOR

• Sinem Omca

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanife Kabukcu

CONTACT

+905337319555; hanifekabukcu@akdeniz.edu.tr

Sinem Omca

CONTACT

+905061187398; snmomca@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TU (1)