Clinical Trial

Effect of Pregabalin on Optic Nerve Sheath Diameter in Craniotomy Patients.

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
When patients undergo brain tumor removal surgery (craniotomy), the pressure inside the skull may increase, which can lead to brain swelling and slower recovery. Currently, doctors measure this pressure using invasive monitors placed inside the brain, but these are not used for all patients. This study investigates whether a medication called pregabalin, given before surgery, can help reduce pressure inside the skull. Pregabalin is already approved for treating pain, anxiety, and seizures. The study will measure pressure indirectly using a simple, painless ultrasound of the eye (optic nerve sheath diameter), which is a validated non-invasive method to estimate intracranial pressure. Participants will be randomly assigned to receive either pregabalin 150 mg or a placebo (inactive pill) on the evening before surgery and again on the morning of surgery. The ultrasound measurement will be taken at four time points: before the first dose, before anesthesia induction, upon arrival to the intensive care unit, and 24 hours after surgery. Researchers will also measure pain levels, medication use, and recovery quality. The goal is to determine if preoperative pregabalin can safely reduce intracranial pressure and improve recovery in craniotomy patients.
Trial Details
NCT Number NCT07630753
Lead Sponsor Benha University
Conditions Pregabalin, Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Changes
Enrollment 100 participants
Start Date 2026-05-25
Primary Completion 2026-12-10 (estimated)
Study Completion 2027-01-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-08