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NCT Number: NCT07482514

Transcranial Doppler and NIRS Monitoring of Cerebral Hemodynamics in 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.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  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

    Regional cerebral oxygen saturation measured continuously by near-infrared spectroscopy (NIRS) during surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanife Kabukcu

CONTACT

[email protected]

+905337319555

Sinem Omca

CONTACT

[email protected]

+905061187398

Sponsors and collaborators

Lead sponsor

Hanife Kabukcu

Other

Registry information

Official study title

Evaluation of Cerebral Hemodynamic Changes Using Transcranial Doppler and Near-Infrared Spectroscopy During Pediatric Laparoscopic Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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