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

R

Republic of Turkey Ministry of Health

Status

Completed

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07370779
LutfiKırdarCityHospital

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

6 months to 18 years old

Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Study Group
Active Comparator group
Description:
PEEP 4 group
Treatment:
Drug: Anesthetic Agents
Device: mechanical ventilation (MV)
Drug: General Anesthesia
Control Group
Active Comparator group
Description:
PEEP 0 Group
Treatment:
Drug: Anesthetic Agents
Device: mechanical ventilation (MV)
Drug: General Anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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