Oral Amantadine, IV Amantadine and Hemodynamic Response to Laryngoscopy

Intubation, Intratracheal Clinical Trial

Official title:

Oral Amantadine Versus IV Amantadine to Attenuate the Hemodynamic Response to Laryngoscopy, Tracheal Intubation and Surgical Incision and Their Effect on β-endorphin: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03612921
• Other study ID #: 17300205
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Intubation, Intratracheal

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