Lidocaine, Dexmedetomidine, Esmolol and Magnesium Effect on Optic Nerve Sheath Diameter After Laryngoscopy

NCT06254534 | Recruiting

• 1 other identifier: 106-2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Hypertension; Endotracheal Intubation; Optic Nerve Sheath Diameter; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• mean arterial pressure

  throughout the anesthesia

• heart rate

  throughout the anesthesia

Study Arms (5)

Control

PLACEBO COMPARATOR

In the control group, only unlabeled saline prepared in 50 ml will be administered intravenously for 10 minutes before general anesthesia induction after standard monitoring on the operating room table.

Diagnostic Test: optic nerve ultrasonography

Lidocaine

EXPERIMENTAL

lidocaine (1.5 mg/kg) within unlabeled saline prepared in 50 ml will be administered intravenously for 10 minutes before general anesthesia induction after standard monitoring on the operating room table.

Diagnostic Test: optic nerve ultrasonography

magnesium

EXPERIMENTAL

magnesium (20 mg/kg) within unlabeled saline prepared in 50 ml will be administered intravenously for 10 minutes before general anesthesia induction after standard monitoring on the operating room table.

Diagnostic Test: optic nerve ultrasonography

dexmedetomidine

EXPERIMENTAL

Dexmedetomidine (1 mcg/kg) within unlabeled saline prepared in 50 ml will be administered intravenously for 10 minutes before general anesthesia induction after standard monitoring on the operating room table.

Diagnostic Test: optic nerve ultrasonography

Esmolol

EXPERIMENTAL

Esmolol (1 mcq/kg) within unlabeled saline prepared in 50 ml will be administered intravenously for 10 minutes before general anesthesia induction after standard monitoring on the operating room table.

Diagnostic Test: optic nerve ultrasonography

Interventions

optic nerve ultrasonography DIAGNOSTIC_TEST

The primary investigator measured ONSD at times: first after anesthesia induction before laryngoscopy, second just after laryngoscopy, third five minutes after, and fourth ten minutes after intubation by ultrasound guidance with a high-frequency linear probe at T2 ophthalmic preset.

Control; Esmolol; Lidocaine; dexmedetomidine; magnesium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Trainig and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 37925899 BACKGROUND

• 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.

  PMID: 37250266 BACKGROUND

• 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.

  PMID: 37693019 BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Berna Caliskan

  Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berna Caliskan, MD

CONTACT

+905067108770; caliskan.b@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The anesthesiology technician selected an envelope in order of numbers written on it and prepared unlabeled saline infusions according to the predetermined protocols of each group. Each group received one of the protocols as lidocaine (1.5 mg/kg), dexmedetomidine (1 mcg/kg), esmolol (1 mcq/kg), and magnesium (20 mg/kg) prepared in 50 ml of unlabeled physiological saline, after standard monitoring on the operating room table. In the control group, only saline was administered intravenously for 10 minutes; then general anesthesia was applied. Along with the study participants, the primary investigator was kept blind to the study groups as the sole applier of the ONSD measurement and the only observer of the hemodynamic changes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Standardized, controlled, randomized, double blind

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 12, 2024
• Study Start: February 14, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)