Oral Amantadine Versus Gabapentin to Attenuate the Response to Laryngoscopy and Tracheal Intubation

Effect of Laryngoscopy and Tracheal Intubation Clinical Trial

— 15/5/2017  

Official title:

Oral Amantadine Versus Gabapentin to Attenuate the Hemodynamic Response to Laryngoscopy and Tracheal Intubation and Their Effect on β-endorphin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172234
• Other study ID #: Assuit universty
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 15, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• ASA I&II scheduled for elective spine surgery

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)

• diabetes mellitus, thyroid disease any endocrine disease

• Suspected difficult intubation or intubation time more than 30 second.

Related Conditions & MeSH terms

• Effect of Laryngoscopy and Tracheal Intubation

Intervention

Other:
• oral amantadine sulfate
In amantadine group:the patients will receive100 mg oral amantadine sulfate 90 minute prior to the surgery

Drug:
• oral gabapentin
In gabapentin group: the patients will receive oral 800 mg gabapentin 90 minute prior to the surgery
• Placebo Oral Tablet
in control group : the patients will receive Placebo Oral Tablet 90 minute prior to the surgery

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Ghada Mohammed AboelFadl

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of oral amantadine versus gabapentin premedication on laryngoscopy and tracheal intubation on ß-endorphins.	analysis of change of ß-endorphins in blood sample	baseline blood sample taken before drug administration and after 15 minutes after intubation and before skin incision
Secondary	effect of oral amantadine versus gabapentin premedication on the Mean arterial blood pressure due to laryngoscopy and tracheal intubation	change of Mean arterial blood pressure	baselineMAP before drug administration and after 15 minutes after intubation and before skin incision
Secondary	effect of oral amantadine versus gabapentin premedication on the heart rate due to laryngoscopy and tracheal intubation	change of heart rate	baseline heart rate before drug administration and after 15 minutes after intubation and before skin incision