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

March 15, 2026 updated by: Hanife Kabukcu

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

Not yet recruiting

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

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Antalya
      • Antalya, Antalya, Turkey (Türkiye)
        • Akdeniz University
        • Contact:
        • Principal Investigator:
          • Sinem Omca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Hanife Kabukcu, Akdeniz University
  • Principal Investigator: Sinem Omca, Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

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)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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