PregabalinNCT07630753
Effect of Pregabalin on Optic Nerve Sheath Diameter in Craniotomy Patients.
A study testing Pregabalin in people with Pregabalin and Optic Nerve Sheath Diameter Measurement, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pregabalin, Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Changes
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2026to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy or breastfeeding for Safety
- Body mass index > 40 kg/m²
- History of substance abuse
- Inability to cooperate with ONSD measurement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Pregabalin on Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure in Elective Craniotomy Patients.
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Pregabalin, Placebo
- Keywords
- Pregabalin, Optic Nerve Sheath Diameter, Intracranial Pressure, Craniotomy, Brain Tumor, Ultrasound, Perioperative Medicine
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately before anesthesia induction on the day of surgery.
Secondary outcomes (3)
Postoperative Pain Scores
Pain intensity measured using the Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst imaginable pain). Assessed at rest.
Measured: 2, 6, 12, and 24 hours after surgery.
Total Opioid Consumption in First 24 Hours
Measured: 24 hours after surgery
Quality of Recovery Score
Quality of Recovery-15 (QoR-15) questionnaire score. The QoR-15 is a 15-item patient-reported outcome measure that assesses five domains of recovery following surgery and anesthesia: physical comfort (5 items), emotional state (4 items), physical independence (2 items), psychological support (2 items), and pain (2 items). Each item is scored from 0 (none of the time / poor recovery) to 10 (all of the time / excellent recovery). The total score ranges from a minimum of 0 to a maximum of 150. Higher scores indicate a better quality of recovery.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start25 May 2026
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregabalinStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630753
- Sponsor's protocol ID
- RC.11.4.2026
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Pregabalin on Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure in Elective Craniotomy Patients.
- ClinicalTrials.gov ID
- NCT07630753
- Acronym / sponsor ID
- RC.11.4.2026
- Keywords
- Pregabalin, Optic Nerve Sheath Diameter, Intracranial Pressure, Craniotomy, Brain Tumor, Ultrasound, Perioperative Medicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin Group | Experimental | Drug: PregabalinParticipants 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. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinPregabalin 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 | Pregabalin Group |
| PlaceboMatching 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. | Drug | Placebo Group |
Primary outcome
Optic Nerve Sheath Diameter (ONSD) at Pre-induction
Time frame: immediately before anesthesia induction on the day of surgery.
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.
3 secondary outcomes
Postoperative Pain Scores
Time frame: 2, 6, 12, and 24 hours after surgery.
Total Opioid Consumption in First 24 Hours
Time frame: 24 hours after surgery
Quality of Recovery Score
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin in people with Pregabalin and Optic Nerve Sheath Diameter Measurement, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic Nerve Sheath Diameter (ONSD) at Pre-induction (time frame: immediately before anesthesia induction on the day of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.