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

NCT07630753 | Active Not Recruiting

• 1 other identifier: RC.11.4.2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pregabalin; Optic Nerve Sheath Diameter; Intracranial Pressure; Craniotomy; Brain Tumor; Ultrasound; Perioperative Medicine

Outcome Measures

Primary Outcomes (1)

• Optic Nerve Sheath Diameter (ONSD) at Pre-induction

  Optic nerve sheath diameter measured by ultrasound. Measurements will be taken 3 mm posterior to the optic disc using a high-frequency linear probe (7.5-12 MHz) placed gently over the closed upper eyelid. Three measurements will be taken from each eye, and the mean value of both eyes will be calculated.

  immediately before anesthesia induction on the day of surgery.

Secondary Outcomes (3)

• Postoperative Pain Scores

  2, 6, 12, and 24 hours after surgery.

• Total Opioid Consumption in First 24 Hours

  24 hours after surgery

• Quality of Recovery Score

  24 hours after surgery

Study Arms (2)

Pregabalin Group

EXPERIMENTAL

Participants in this arm will receive pregabalin 150 mg orally on the evening before surgery (approximately 8:00 PM) and a second dose of pregabalin 150 mg orally 90 minutes before anesthesia induction on the day of surgery.

Drug: Pregabalin

Placebo Group

PLACEBO COMPARATOR

Participants in this arm will receive matching placebo capsules (containing microcrystalline cellulose) orally on the evening before surgery (approximately 8:00 PM) and a second matching placebo capsule orally 90 minutes before anesthesia induction on the day of surgery. The placebo capsules are identical in appearance, size, color, and taste to the pregabalin capsules.

Drug: Placebo

Interventions

Pregabalin DRUG

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.

Pregabalin Group

Placebo DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years
• ASA status: I-III
• Surgery Elective supratentorial craniotomy for tumor resection (meningioma, glioma, metastasis)
• Anesthesia: General anesthesia with sevoflurane
• Consent: Written informed consent obtained

You may not qualify if:

• Known hypersensitivity to pregabalin or gabapentinoids.
• Pre-existing optic nerve pathology or glaucoma that could cause ONSD measurement interference.
• Emergency surgery as No preoperative dosing window
• Preoperative ICP elevation (suspected or confirmed) to avoid Baseline ICP abnormality
• Severe renal impairment (CrCl \< 30 mL/min).
• Preoperative use of gabapentinoids or benzodiazepines to avoid drug interaction/interference
• Pregnancy or breastfeeding for Safety
• Body mass index \> 40 kg/m²
• History of substance abuse
• Inability to cooperate with ONSD measurement

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesia and intensive care

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)