Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care
NCT07542470
Laminectomy, Spinal Fusion
Sarasota, Florida, United States
View Trial DetailsNCT Number: NCT07067008
Laminectomy surgeries, typically performed for lumbar disc herniation and spinal disorders, are often lengthy surgical procedures requiring patients to be in the prone position. While this position provides better visibility of the surgical field, it can lead to physiological changes in intraocular pressure (IOP) in anesthetized patients. An increase in IOP, though rare, has the potential to cause severe ocular complications such as postoperative vision loss (POVL), which is one of the most feared complications after spinal surgery.
One of the main mechanisms of IOP elevation in the prone position is the impediment of venous return in the head and neck region due to gravity, leading to an increase in episcleral venous pressure. Additionally, direct mechanical pressure on the face and globe can also increase IOP. Anesthesia management can also play a role in IOP dynamics by affecting intrathoracic pressure and venous return. This complex interaction necessitates careful monitoring of eye health in anesthetized patients in the prone position. Non-contact tonometers offer a non-invasive, rapid, and reliable method for IOP measurement. They are particularly advantageous for repeated measurements in anesthetized patients. This clinical study aims to evaluate changes in IOP using a non-contact tonometer in patients undergoing laminectomy in the prone position and to identify anesthesia- and patient-related factors influencing these changes. The data obtained will contribute to the development of anesthesia and positioning strategies aimed at reducing the risk of ocular complications.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with ASA physical status I-II-III
Patients who can cooperate postoperatively
Patients without eye diseases or conditions affecting eye physiology (such as glaucoma)
Patients who have not undergone eye surgery
Patients who consent to participate in the study
Exclusion criteria
Patients with ASA physical status IV-V
Patients who do not consent to participate in the study
Patients who cannot cooperate postoperatively
Patients with eye diseases or conditions affecting eye physiology (such as glaucoma)
Patients who have undergone eye surgery
Patients from whom consent cannot be obtained
Time frame: half an hour
Elazıg Fethi Sekin Sehir Hastanesi
Other
Measurement of Intraocular Pressure (With Non-contact Tonometer) in Patients Undergoing Laminectomy in the Prone Position: A Clinical Study
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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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