Effect of Laryngoscopy and Tracheal IntubationPhase 2/315/5/2017NCT03172234
Oral Amantadine Versus Gabapentin to Attenuate the Response to Laryngoscopy and Tracheal Intubation
A Phase 2/3 study testing oral amantadine sulfate and oral gabapentin in people with Effect of Laryngoscopy and Tracheal Intubation, run by Ghada Mohammed AboelFadl at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Effect of Laryngoscopy and Tracheal Intubation
- What is being tested?
- oral amantadine sulfate and oral gabapentin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2017to 15 May 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I\&II scheduled for elective spine surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Amantadine Versus Gabapentin to Attenuate the Hemodynamic Response to Laryngoscopy and Tracheal Intubation and Their Effect on β-endorphin
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.
Read the 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.
- Being tested
- oral amantadine sulfate, oral gabapentin, Placebo Oral Tablet
- Keywords
- β-endorphins,laryngoscopy and tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral amantadine sulfateOther
Also called infex
In amantadine group:the patients will receive100 mg oral amantadine sulfate 90 minute prior to the surgery
oral gabapentinDrug
Also called gabapentin
In gabapentin group: the patients will receive oral 800 mg gabapentin 90 minute prior to the surgery
Placebo Oral TabletDrug
in control group : the patients will receive Placebo Oral Tablet 90 minute prior to the surgery
| Study group | Role | What they receive |
|---|---|---|
| amantadine group (Group A) | Active comparator | 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. Receives: Other: oral amantadine sulfate |
| gabapentin group(Group B) | Active comparator | the patients will receive oral gabapentin using the dose 800 mg 120 minutes prior to surgery,5 ml saline IV 5 minutes before intubation. Receives: Drug: oral gabapentin |
| control group (group C) | Placebo comparator | the patients will receive placebo oral tablet 120 minutes prior to surgery, IV fentanyl 2µ/kg in 5 ml saline 5 minutes before intubation. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of oral amantadine versus gabapentin premedication on laryngoscopy and tracheal intubation on β-endorphins.
analysis of change of β-endorphins in blood sample
Measured: baseline blood sample taken before drug administration and after 15 minutes after intubation and before skin incision
Secondary outcomes (2)
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
Measured: baselineMAP before drug administration and after 15 minutes after intubation and before skin incision
effect of oral amantadine versus gabapentin premedication on the heart rate due to laryngoscopy and tracheal intubation
change of heart rate
Measured: baseline heart rate before drug administration and after 15 minutes after intubation and before skin incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start15 Jun 2017
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Laryngoscopy and Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghada Mohammed AboelFadl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ghada Mohammed AboelFadl, Assiut University
- Investigators
- Abualauon Elpiplaoy, MD, Principal investigator, Assiut UniversityAhmed El shanawany, MD, Study chair, Assiut UniversityAzza Abo Elfadl El Sayed, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172234
- Sponsor's protocol ID
- Assuit universty
- Acronym
- 15/5/2017
- Status last verified
- Sep 2018
- First submitted
- 20 May 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Amantadine Versus Gabapentin to Attenuate the Hemodynamic Response to Laryngoscopy and Tracheal Intubation and Their Effect on β-endorphin
- ClinicalTrials.gov ID
- NCT03172234
- Acronym / sponsor ID
- 15/5/2017 / Assuit universty
- Keywords
- β-endorphins,laryngoscopy and tracheal intubation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ghada Mohammed AboelFadlUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| amantadine group (Group A) | Active comparator | Other: oral amantadine sulfatethe 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. |
| gabapentin group(Group B) | Active comparator | Drug: oral gabapentinthe patients will receive oral gabapentin using the dose 800 mg 120 minutes prior to surgery,5 ml saline IV 5 minutes before intubation. |
| control group (group C) | Placebo comparator | Drug: Placebo Oral Tabletthe patients will receive placebo oral tablet 120 minutes prior to surgery, IV fentanyl 2µ/kg in 5 ml saline 5 minutes before intubation. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I\&II scheduled for elective spine surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral amantadine sulfateAlso: infexIn amantadine group:the patients will receive100 mg oral amantadine sulfate 90 minute prior to the surgery | Other | amantadine group (Group A) |
| oral gabapentinAlso: gabapentinIn gabapentin group: the patients will receive oral 800 mg gabapentin 90 minute prior to the surgery | Drug | gabapentin group(Group B) |
| Placebo Oral Tabletin control group : the patients will receive Placebo Oral Tablet 90 minute prior to the surgery | Drug | control group (group C) |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Effect of Laryngoscopy and Tracheal Intubation
Recruiting
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One Lung Ventilation in Thoracic Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abualauon Elpiplaoy, MD principal investigator
Assiut University
Ahmed El shanawany, MD study chair
Assiut University
Azza Abo Elfadl El Sayed, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing oral amantadine sulfate and oral gabapentin in people with Effect of Laryngoscopy and Tracheal Intubation, run by Ghada Mohammed AboelFadl at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.