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NCT Number: NCT07370779

The Effect Of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter In Pediatric Patients Undergoing Craniotomy in Supine Position

This study evaluated the effect of positive end-expiratory pressure (PEEP) on optic nerve sheath diameter (ONSD), an indicator of intracranial pressure, in pediatric patients undergoing craniotomy in the supine position. The findings indicated that the application of PEEP did not result in a significant difference in ONSD. Although a significant decrease in systolic and diastolic blood pressure was observed with the use of PEEP, these values remained within normal ranges and did not indicate adverse hemodynamic effects. The results suggest that the use of a PEEP level of 4 cmH2O in pediatric patients with intracranial masses is safe and may be applied during the perioperative period.

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Key information

Conditions

Craniotomy Surgery Optic Nerve Sheath Diameter Measurement Pediatric Patient Pediatric Patient Safety Positive End-expiratory Pressure (PEEP)

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Lutfi Kırdar City Hospital

Istanbul, eyüpsultan, 34077, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pediatric patients aged 6 months to 18 years
  • American Society of Anesthesiologists (ASA) physical status III
  • Scheduled for elective craniotomy in the supine position
  • Presence of an extra-axial intracranial mass
  • Written informed consent obtained from parents or legal guardians

Exclusion criteria

  • Open fontanelles
  • Orbital pathology
  • Severe increases in intracranial pressure associated with nausea, vomiting, visual disturbances, or seizures
  • Radiologic or clinical signs of brain herniation
  • Hydrocephalus
  • Cerebral infection
  • Congenital syndromes
  • History of surgery involving the optic nerve
  • Use of inotropic therapy
  • Hemodynamic instability
  • Surgical complications during the operation or procedures lasting longer than 8 hours
  • Postoperative intubation requiring intensive care unit follow-up
  • Tumors invading the optic nerve
  • Inability to obtain written informed consent from parents or legal guardians

Treatment and study plan

General anesthesia

Drug

General anesthesia was administered according to standard clinical practice, including intravenous induction agents and inhalational anesthetics, as part of routine perioperative care.

Anesthetic Agents

Drug

Anesthetic agents, including propofol, fentanyl, rocuronium, and sevoflurane, were used as part of standard anesthetic management during the procedure.

mechanical ventilation (MV)

Device

Mechanical ventilation was provided using a standard anesthesia ventilator in volume-controlled mode during surgery.

Primary outcomes

  1. optic nerve sheath diameter

    Time frame: Four times in during the operation by using ultrasonography. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation

Secondary outcomes

  1. Heart Rate

    Time frame: Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation

  2. systolic blood pressure

    Time frame: Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation

  3. diastolic blood pressure

    Time frame: Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation

  4. Peripheral oxygen saturation

    Time frame: Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2026
Registry last updated
Jan 27, 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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