General Anesthesia Clinical Trial
Official title:
Effect of Lidocaine, Dexmedetomidine, Esmolol and Magnesium Use on Optic Nerve Sheath Diameter and Hemodynamic Response After Laryngoscopy: Randomized, Controlled, Double-blind Trial
NCT number | NCT06254534 |
Other study ID # | 106-2021 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 14, 2024 |
Est. completion date | July 2024 |
This clinical trial aims to compare the effects of lidocaine, dexmedetomidine, esmolol, and magnesium on optic nerve sheath diameter and hemodynamic response to laryngoscopy. The participants will be patients determined to need intubation and general anesthesia for any elective surgery. Each participant will receive either lidocaine, dexmedetomidine, esmolol, magnesium, or none before anesthesia induction, according to randomization. The investigator will measure the optic nerve sheath diameter by ultrasonography before and after intubation. Researchers will compare the difference between optic nerve sheath diameter, systolic blood pressure, and heart rate before and after laryngoscopy and search for the most stable group. The trial aims to determine a general anesthesia induction protocol for patients sensitive to intracranial pressure changes reflected as optic nerve sheath diameter for easy monitoring.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Haseki Trainig and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Haseki Training and Research Hospital |
Turkey,
Berhanu D, Ferreira JC, Abegao Pinto L, Aguiar de Sousa D, Lucas Neto L, Tavares Ferreira J. The role of optic nerve sheath ultrasonography in increased intracranial pressure: A systematic review and meta analysis. J Neurol Sci. 2023 Nov 15;454:120853. doi: 10.1016/j.jns.2023.120853. Epub 2023 Oct 30. — View Citation
Grover N, Taneja R, Rashid Y, Shrivastava N. Nebulised fentanyl, dexmedetomidine and magnesium sulphate for attenuation of haemodynamic response to laryngoscopy and tracheal intubation: A double-blinded, randomised comparative study. Indian J Anaesth. 2023 Aug;67(8):730-735. doi: 10.4103/ija.ija_397_22. Epub 2023 Aug 15. — View Citation
Sriramka B, Warsi ZH, Sahoo J. Effects of adding dexmedetomidine to nebulized lidocaine on control of hemodynamic responses to laryngoscopy and intubation: A randomized clinical trial. J Anaesthesiol Clin Pharmacol. 2023 Jan-Mar;39(1):11-17. doi: 10.4103/joacp.JOACP_93_21. Epub 2022 Feb 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | optic nerve sheath diameter | optic nerve sheath ultrasonography will be used to measure optic nerve sheath diameter with a high-frequency linear probe at T2 ophthalmic preset at a distance of 3 mm from the posterior globe | throughout the anesthesia | |
Secondary | mean arterial pressure | mean arterial pressure will be recorded at times of optic nerve sheath measurements | throughout the anesthesia | |
Secondary | heart rate | heart rate will be recorded at times of optic nerve sheath measurements | throughout the anesthesia |
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