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Completed

NCT Number: NCT03172234

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

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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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university hospitals

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral amantadine sulfate

Other

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

Other names: infex

oral gabapentin

Drug

In gabapentin group: the patients will receive oral 800 mg gabapentin 90 minute prior to the surgery

Other names: gabapentin

Placebo oral tablet

Drug

in control group : the patients will receive Placebo Oral Tablet 90 minute prior to the surgery

Primary outcomes

  1. effect of oral amantadine versus gabapentin premedication on laryngoscopy and tracheal intubation on β-endorphins.

    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

Secondary outcomes

  1. effect of oral amantadine versus gabapentin premedication on the Mean arterial blood pressure due to laryngoscopy and tracheal intubation

    Time frame: baselineMAP before drug administration and after 15 minutes after intubation and before skin incision

    change of Mean arterial blood pressure

  2. effect of oral amantadine versus gabapentin premedication on the heart rate due to laryngoscopy and tracheal intubation

    Time frame: baseline heart rate before drug administration and after 15 minutes after intubation and before skin incision

    change of heart rate

Sponsors and collaborators

Lead sponsor

Ghada Mohammed AboelFadl

Unknown

Registry information

Official study title

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

Acronym: 15/5/2017

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2017
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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