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

Overview

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.

This study is a prospective, randomized, double-blind, placebo-controlled trial. It will be conducted in the operating rooms and neurosurgical intensive care unit at the study hospital. The study population consists of adult patients aged eighteen to sixty-five years who are scheduled for elective supratentorial craniotomy to remove a brain tumor. Participants will be randomly assigned in a one-to-one ratio to receive either pregabalin 150 mg or an identical placebo capsule. The study drug will be administered orally on the evening before surgery and again ninety minutes before anesthesia induction on the day of surgery. Neither the participants nor the treating physicians or outcome assessors will know which group the participant belongs to. The primary outcome of the study is the optic nerve sheath diameter measured by ultrasound at the pre-induction time point, which is ninety minutes after the second dose of the study drug. An optic nerve sheath diameter greater than 5.5 millimeters is considered indicative of elevated intracranial pressure. Secondary outcomes include optic nerve sheath diameter at baseline, upon intensive care unit arrival, and twenty-four hours after surgery; the incidence of elevated optic nerve sheath diameter at each time point; postoperative pain scores; total opioid consumption in the first twenty-four hours; time to first pain medication request; the incidence of postoperative delirium; quality of recovery scores; preoperative anxiety levels; and any adverse events such as sedation, dizziness, nausea, or vomiting. The sample size is one hundred participants, with fifty participants in each group. This calculation was based on an expected difference of 0.3 millimeters in optic nerve sheath diameter between groups, a standard deviation of 0.5 millimeters, an alpha level of 0.05, a power of eighty percent, and an anticipated ten percent dropout rate. Anesthesia will be standardized for all participants using sevoflurane for maintenance. Fentanyl will be used for intraoperative pain control, and the total amount given will be recorded. Optic nerve sheath diameter measurements will be performed using a high-frequency linear ultrasound probe placed gently over the closed eyelid. Three measurements will be taken from each eye, and the average will be calculated. Statistical analysis will follow the intention-to-treat principle, meaning participants will be analyzed according to the group they were originally assigned to regardless of whether they completed the study protocol. Continuous measurements will be compared using appropriate statistical tests, and a p-value less than 0.05 will be considered statistically significant. Adverse events will be recorded throughout the hospital stay. Participants who develop severe sedation will be withdrawn from the study. The study protocol has been approved by the institutional review board, and written informed consent will be obtained from all participants. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Recruitment is currently ongoing, and the study is expected to take approximately eighteen months to complete.