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

NCT ID: NCT03172234

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2018-05-15

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.

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.

Conditions

Effect of Laryngoscopy and Tracheal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

oral amantadine sulfate

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

oral gabapentin

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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

Interventions

oral amantadine sulfate

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

Intervention Type: OTHER

oral gabapentin

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

Intervention Type: DRUG

Placebo Oral Tablet

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

Intervention Type: DRUG

Other Intervention Names

infex; gabapentin

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ghada Mohammed AboelFadl

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohammed AboelFadl

principal-investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abualauon Elpiplaoy, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Ahmed El shanawany, MD

Role: STUDY_CHAIR

Assiut University

Azza Abo Elfadl El Sayed, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut university hospitals

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Assuit universty

Identifier Type: -

Identifier Source: org_study_id