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Oral Amantadine Versus Gabapentin to Attenuate the Response to Laryngoscopy and Tracheal Intubation (15/5/2017)

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ClinicalTrials.gov Identifier: NCT03172234
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, Assiut University

Brief 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.

Condition or disease Intervention/treatment Phase
Effect of Laryngoscopy and Tracheal Intubation Other: oral amantadine sulfate Drug: oral gabapentin Drug: Placebo Oral Tablet Phase 2 Phase 3

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. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Oral Amantadine Versus Gabapentin to Attenuate the Hemodynamic Response to Laryngoscopy and Tracheal Intubation and Their Effect on β-endorphin
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: amantadine group (Group A)
the patients will receive oral amantadine sulfate using the dose 100 mg 120 minutes prior to the surgery, 5 ml saline IV 5 minutes before intubation.
Other: oral amantadine sulfate
In amantadine group:the patients will receive100 mg oral amantadine sulfate 90 minute prior to the surgery
Other Name: infex

Active Comparator: gabapentin group(Group B)
the patients will receive oral gabapentin using the dose 800 mg 120 minutes prior to surgery,5 ml saline IV 5 minutes before intubation.
Drug: oral gabapentin
In gabapentin group: the patients will receive oral 800 mg gabapentin 90 minute prior to the surgery
Other Name: gabapentin

Placebo Comparator: control group (group C)
the patients will receive placebo oral tablet 120 minutes prior to surgery, IV fentanyl 2µ/kg in 5 ml saline 5 minutes before intubation.
Drug: Placebo Oral Tablet
in control group : the patients will receive Placebo Oral Tablet 90 minute prior to the surgery




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172234


Locations
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Egypt
Assiut university hospitals
Assiut, Egypt
Sponsors and Collaborators
Ghada Mohammed AboelFadl
Investigators
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Principal Investigator: Abualauon Elpiplaoy, MD Assiut University
Study Chair: Ahmed El shanawany, MD Assiut University
Principal Investigator: Azza Abo Elfadl El Sayed, MD Assiut University

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Responsible Party: Ghada Mohammed AboelFadl, principal-investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03172234     History of Changes
Other Study ID Numbers: Assuit universty
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ghada Mohammed AboelFadl, Assiut University:
β-endorphins,laryngoscopy and tracheal intubation

Additional relevant MeSH terms:
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Amantadine
Gabapentin
Endorphins
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Analgesics, Non-Narcotic