Clinical trial NCT03612921: Oral Amantadine, IV Amantadine and Hemodynamic Response to Laryngoscopy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intubation, Intratracheal
Keywords: oral amantadine
IV amantadine
tracheal intubation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the effect of oral amantadine versus IV amantadine premedication on laryngoscopy and tracheal intubation on β-endorphins .
timeFrame: 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 outcomes:
measure: the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to surgical incision
timeFrame: 2 blood samples one just before medication and the second after 10 minutes after skin incision
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
affiliation: Assiut, Assiut governorate, Egypt, 715715
name: Ghada Abu El Fadl, MD
role: PRINCIPAL_INVESTIGATOR
References: