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

NCT07630753 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-08

No results posted yet for this study

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.

Conditions

  • Pregabalin
  • Optic Nerve Sheath Diameter Measurement
  • Intracranial Pressure Changes

Interventions

DRUG

Pregabalin

Pregabalin 150 mg capsule administered orally. Participants receive one capsule on the evening before surgery (approximately 8:00 PM) and a second capsule 90 minutes before anesthesia induction on the day of surgery. Each capsule contains 150 mg of pregabalin as the active ingredient. The drug is given with 30 mL of water. Pregabalin is a gamma-aminobutyric acid (GABA) analogue that binds to the alpha2-delta subunit of voltage-gated calcium channels, reducing the release of excitatory neurotransmitters including glutamate, noradrenaline, and substance P. This intervention is being tested for its potential neuroprotective effect and ability to reduce intracranial pressure as measured by optic nerve sheath diameter.

DRUG

Placebo

Matching placebo capsule containing microcrystalline cellulose administered orally. Participants receive one capsule on the evening before surgery (approximately 8:00 PM) and a second capsule 90 minutes before anesthesia induction on the day of surgery. The placebo capsules are identical in appearance, size, color, and taste to the pregabalin 150 mg capsules to maintain blinding. The placebo contains no active pharmaceutical ingredient.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-25
Primary Completion
2026-12-10
Completion
2027-01-10

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630753 on ClinicalTrials.gov