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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07370779
Enrollment
30
Registered
2026-01-27
Start date
2021-01-01
Completion date
2021-10-30
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

peep, pediatric patients, optic nerve sheath diameter, intracranial pressure, craniotomy

Brief summary

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.

Interventions

DRUGGeneral Anesthesia

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

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

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

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Intervention model description

The initial group (Study Group) received a PEEP level of 4 cmH2O. Tthe second group (Control Group) received no PEEP.

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
optic nerve sheath diameterFour 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

MeasureTime frame
Heart RateFour 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
systolic blood pressureFour 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
diastolic blood pressureFour 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
Peripheral oxygen saturationFour 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026