Effects of lidocaine, dexmedetomidine, esmolol, and magnesium on optic nerve sheath diameter during intubation
Effect of Lidocaine, Dexmedetomidine, Esmolol and Magnesium Use on Optic Nerve Sheath Diameter and Hemodynamic Response After Laryngoscopy: Randomized, Controlled, Double-blind Trial
This study is testing four different medications to see which one best helps keep the optic nerve safe during intubation for patients needing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Haseki Training and Research Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06254534 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effects of four different medications—lidocaine, dexmedetomidine, esmolol, and magnesium—on the optic nerve sheath diameter and hemodynamic responses during laryngoscopy and endotracheal intubation. Patients aged 18 to 80 who require intubation for elective surgery will be randomly assigned to receive one of the medications or none before anesthesia induction. The study will utilize ultrasonography to measure changes in optic nerve sheath diameter before and after intubation, aiming to identify the most stable medication regimen for patients sensitive to intracranial pressure changes. This approach seeks to optimize management for patients with limited physiological reserves.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 80 requiring endotracheal intubation for general anesthesia with an ASA Physical Status classification of I to III.
Not a fit: Patients with allergies to the study medications, uncontrolled hypertension, advanced heart failure, or known intracranial pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved protocols for general anesthesia induction in patients at risk for intracranial pressure changes.
How similar studies have performed: While the approach of using optic nerve sheath diameter as a monitoring tool is gaining traction, this specific combination of medications and their effects on ONSD during intubation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 to 80 years who will receive endotracheal intubation for general anesthesia and have an American Society of Anesthesiologists (ASA) Physical Status classification of I to III. Exclusion Criteria: * Patients allergic to dexmedetomidine, esmolol, lidocaine, and magnesium; patients with uncontrolled hypertension or advanced heart failure with EF below 35%; patients with cardiac arrhythmia, especially Type 2 and 3 blocks, supraventricular arrhythmias. Patients with renal failure (GFR below 30) or severe liver failure; patients with known acute or previous intracranial pathology and known diagnosis of epilepsy, predefined difficult airway examination. Patients who required more than one attempt at intubation or total laryngoscopy took more than 20 seconds.
Where this trial is running
Istanbul
- Haseki Trainig and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Berna Caliskan — Anesthesiology and Reanimation Department
- Study coordinator: Berna Caliskan, MD
- Email: caliskan.b@gmail.com
- Phone: +905067108770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.