Assiut university hospitals
Asyut, Egypt
NCT Number: NCT03172234
To evaluate the effect of oral amantadine versus gabapentin premedication on the hemodynamic response to laryngoscopy and tracheal intubation and their effect on β-endorphins.
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Notify Me20 year–55 year
All sexes
Interventional
Phase 2 / Phase 3
Asyut, Egypt
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. Gabapentin, is 1-aminomethyl cyclohexane acetic acid.Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA). Gabapentin act in central nervous system CNS), it acts by decreasing the synthesis of neurotransmitter glutamate and by binding to the alpha 2 delta subunits of voltage dependent calcium channels.
Amantadine is a non-competitive N-methyl-D-aspartate (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.
The investigators designed this study to prove the efficacy of oral amantadine versus gabapentin premedication on the hemodynamic response to laryngoscopy and tracheal intubation and their effect on β-endorphins.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In amantadine group:the patients will receive100 mg oral amantadine sulfate 90 minute prior to the surgery
Other names: infex
In gabapentin group: the patients will receive oral 800 mg gabapentin 90 minute prior to the surgery
Other names: gabapentin
in control group : the patients will receive Placebo Oral Tablet 90 minute prior to the surgery
Time frame: baseline blood sample taken before drug administration and after 15 minutes after intubation and before skin incision
analysis of change of β-endorphins in blood sample
Time frame: baselineMAP before drug administration and after 15 minutes after intubation and before skin incision
change of Mean arterial blood pressure
Time frame: baseline heart rate before drug administration and after 15 minutes after intubation and before skin incision
change of heart rate
Ghada Mohammed AboelFadl
Unknown
Oral Amantadine Versus Gabapentin to Attenuate the Hemodynamic Response to Laryngoscopy and Tracheal Intubation and Their Effect on β-endorphin
Acronym: 15/5/2017
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