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NCT07630753
Effect of Pregabalin on Optic Nerve Sheath Diameter in Craniotomy Patients.
Conditions: Pregabalin, Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Changes
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Benha University
Location: Benha University Hospital Banhā Qalyubia Governorate
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.
Eligibility Criteria
Inclusion Criteria:
1. Age: 18-65 years
2. ASA status: I-III
3. Surgery Elective supratentorial craniotomy for tumor resection (meningioma, glioma, metastasis)
4. Anesthesia: General anesthesia with sevoflurane
5. Consent: Written informed consent obtained
Exclusion Criteria:
1. Known hypersensitivity to pregabalin or gabapentinoids.
2. Pre-existing optic nerve pathology or glaucoma that could cause ONSD measurement interference.
3. Emergency surgery as No preoperative dosing window
4. Preoperative ICP elevation (suspected or confirmed) to avoid Baseline ICP abnormality
5. Severe renal impairment (CrCl \< 30 mL/min).
6. Preoperative use of gabapentinoids or benzodiazepines to avoid drug interaction/interference
7. Pregnancy or breastfeeding for Safety
8. Body mass index \> 40 kg/m²
9. History of substance abuse
10. Inability to cooperate with ONSD measurement
Source: ClinicalTrials.gov (NCT07630753). StuddyBuddy aggregates publicly available trial information.