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

NCT07370779 — Not applicable, Completed, 30 participants, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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Registry	NCT07370779
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, other
Enrollment	30 (Actual)
Sponsor	Dr. Lutfi Kirdar Kartal Training and Research Hospital (Other gov)
Conditions	Craniotomy Surgery, Pediatric Patient Safety, Pediatric Patient, Positive End-expiratory Pressure (PEEP), Optic Nerve Sheath Diameter Measurement
Interventions	General Anesthesia, Anesthetic Agents, mechanical ventilation (MV) (Drug, device)
Dates	start 2021-01-01, primary completion 2021-10-30, completion 2021-10-30, first posted 2026-01-27, last updated 2026-01-27
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Study Group	Active comparator	Drug: General Anesthesia; Drug: Anesthetic Agents; Device: mechanical ventilation (MV)	PEEP 4 group
Control Group	Active comparator	Drug: General Anesthesia; Drug: Anesthetic Agents; Device: mechanical ventilation (MV)	PEEP 0 Group

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.

+Outcome measures

Primary outcomes

optic nerve sheath diameter [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

Heart Rate [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]
systolic blood pressure [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]
diastolic blood pressure [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]
Peripheral oxygen saturation [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]

+Eligibility

Sex: All, ages: 6 Months to 18 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Dr Lutfi Kırdar City Hospital	Istanbul, eyüpsultan	Turkey (Türkiye)

+Publications

Sezen O, Saracoglu KT, Simsek T, Cevik B, Aydogmus E. The effect of positive end-expiratory pressure on optic nerve diameter in patients undergoing craniotomy operation. Ann Clin Anal Med. 2021;12(02):199-203.
Pulitano S, Mancino A, Pietrini D, Piastra M, De Rosa S, Tosi F, De Luca D, Conti G. Effects of positive end expiratory pressure (PEEP) on intracranial and cerebral perfusion pressure in pediatric neurosurgical patients. J Neurosurg Anesthesiol. 2013 Jul;25(3):330-4. doi: 10.1097/ANA.0b013e31828bac4d. PMID 23519374
Padayachy L, Brekken R, Fieggen G, Selbekk T. Noninvasive Transorbital Assessment of the Optic Nerve Sheath in Children: Relationship Between Optic Nerve Sheath Diameter, Deformability Index, and Intracranial Pressure. Oper Neurosurg. 2019 Jun 1;16(6):726-733. doi: 10.1093/ons/opy231. PMID 30169680
Khandelwal A, Kapoor I, Mahajan C, Prabhakar H. Effect of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter in Pediatric Patients with Traumatic Brain Injury. J Pediatr Neurosci. 2018 Apr-Jun;13(2):165-169. doi: 10.4103/jpn.JPN_112_17. PMID 30090129