Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03612921
Other study ID # 17300205
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 15, 2018
Est. completion date April 1, 2022

Study information

Verified date November 2021
Source Assiut University
Contact Ghada Abu El Fadl, MD
Phone 01005802086
Email ghadafadl77@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this study will be undertaken-to evaluate the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to laryngoscopy ,tracheal intubation and surgical incision and their effect on β-endorphins.


Description:

Direct laryngoscopy and passage of endotracheal tube through the larynx is a noxious stimulus, which can provoke untoward response in the cardiovascular, respiratory and other physiological systems .Amantadine is a non-competitive NMDA receptor antagonist, and compared to ketamine, it is well tolerated with fewer side effects (mainly dizziness, sedation, and dry mouth). Amantadine's formulation permits the oral route for drug delivery, as well as the IV route. The side-effects profile of amantadine via all routes seems not to be harmful in appropriate dosages.. Amantadine has been clinically used as an antiviral drug, for dementia, and in the treatment of Parkinson's disease and spasticity. It is a non-competitive NMDA receptor antagonist, and compared to ketamine, it is well tolerated with fewer side effects (mainly dizziness, sedation, and dry mouth). Amantadine's formulation permits the oral route for drug delivery, as well as the IV route. The side-effects profile of amantadine via all routes seems not to be harmful in appropriate dosages. In the central nervous system, beta-endorphins bind mu-opioid receptors and exert their primary action at presynaptic nerve terminals. However, instead of inhibiting substance P, they exert their analgesic effect by inhibiting the release of GABA, an inhibitory neurotransmitter, resulting in excess production of dopamine. this study will be undertaken-to evaluate the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to laryngoscopy ,tracheal intubation and surgical incision and their effect on β-endorphins.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - ASA I&II - the age range 20-55 years scheduled for elective back surgery(laminectomy, discectomy and spinal canal stenosis) Exclusion Criteria: - Patient refusal - Patients with ASA score III (with chronic kidney, lungs, Gastrointestinal tract, liver, or cardiovascular diseases) - Pregnant or breastfeeding women. - Allergy to any of the study medications and taking medications that could significantly interact with amantadine (tramadol, atropine, antipsychotic medications) - DM, thyroid disease any endocrine disease - Suspected difficult intubation or intubation time more than 30 second.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
oral Amantadine sulfate
oral amantadine
i.v Amantadine Sulfate
intra venous amantadine
placebo tablet
placebo tablet

Locations

Country Name City State
Egypt Assiut university hospitals Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary the effect of oral amantadine versus IV amantadine premedication on laryngoscopy and tracheal intubation on ß-endorphins . changes of the mean arterial blood pressure (mmhg) baseline( before medication) , 5 minutes before induction of anaesthesia, 3 minutes after induction , 5 minutes after tracheal intubation and 5 minutes after skin incision
Secondary the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to surgical incision ß-endorphins level in the blood 2 blood samples one just before medication and the second after 10 minutes after skin incision
See also
  Status Clinical Trial Phase
Completed NCT04994652 - Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns N/A
Completed NCT03301324 - Intubation Assist Clinical Study N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Not yet recruiting NCT04116333 - Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin N/A
Recruiting NCT02001285 - Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Double-lumen Endobronchial Intubation N/A
Completed NCT02034643 - Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure N/A
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01227486 - Verification of Endotracheal Tube Placement by Ultrasound in the Obese Patient N/A
Withdrawn NCT01252173 - Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients N/A
Completed NCT04591769 - Tracheal Tube Cuff Shape and Pressure N/A
Completed NCT03841890 - The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure N/A
Recruiting NCT03716713 - CeraShield™ Endotracheal Tube Feasibility Study N/A
Not yet recruiting NCT03938506 - The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes
Not yet recruiting NCT01974505 - Learning Curve of Optiscope by Anesthesia Providers N/A
Completed NCT06107998 - Comparison of Different Methods for Determining Endotracheal Cuff Pressure N/A
Completed NCT02822846 - Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography
Completed NCT03116373 - Impact of Tracheal Tube Fixing Site on Its Mobility During Head Mobilization N/A
Completed NCT02423317 - Comparison of Miller's Blade and Airtraq Laryngoscope in Children N/A
Completed NCT04863846 - Evidence-based Algorithm for the Expected Difficult Intubation
Not yet recruiting NCT04872881 - Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy Phase 4