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

NCT07370779 | Completed

• 1 other identifier: LutfiKırdarCityHospital
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• 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

Study Arms (2)

Study Group

ACTIVE COMPARATOR

PEEP 4 group

Drug: General Anesthesia; Drug: Anesthetic Agents; Device: mechanical ventilation (MV)

Control Group

ACTIVE COMPARATOR

PEEP 0 Group

Drug: General Anesthesia; Drug: Anesthetic Agents; Device: mechanical ventilation (MV)

Interventions

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.

Control Group; Study Group

Anesthetic Agents DRUG

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

Control Group; Study Group

mechanical ventilation (MV) DEVICE

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

Control Group; Study Group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Dr Lutfi Kırdar City Hospital

Istanbul, eyüpsultan, 34077, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Anesthesia, General; Anesthetics; Respiration, Artificial

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md

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

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 27, 2026
• Study Start: January 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TU (1)