The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.
NCT ID: NCT06887998
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
63 participants
INTERVENTIONAL
2025-03-31
2026-03-31
Brief Summary
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While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children.
Emergence agitation is a common phenomenon occurring in 22.2% in adult patients undergoing general anesthesia for nasal surgery .
Gabapentin, agamma-aminobutyricacidanalog, binds the voltage-gated calcium channels of the dorsal root ganglion, at α2-δ subunite. Gabapentin binding to these channels reduces the release of excitatory neurotransmitters preventing the propagation of painful stimuli which makes its use helpful in treatment of postoperative pain and agitation with less side effects compared with benzodiazepines and opioids . Gabapentin has been used in controlling acute perioperative conditions like preoperative anxiety, intraoperative attenuation of hemodynamic response to noxious stimuli and post operative pain, delirium and nausea and vomiting.
A previous study examined the effect of oral gabapentin 600 mg in reducing emergence agitation in adult patients undergowing rhinoplasty, but this study will examine the effect of two different doses of oral gabapentin 400 mg and 600 mg in reducing emergence agitation after nasal surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
* Group (A) \[n = 21 patients\]: will receive 600 mg oral gabapentin one hour before induction.
* Group(B) \[n =21 patients \]:will receive 400 mg oral gabapentin one hour before induction.
* Group (C) (control group) \[n =21 patients \] : will receive placebo
Study Groups
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Gabapentin 600 mg group
21 patients will receive 600 mg oral gabapentin one hour before induction.
Gabapentin 600 mg capsules
21 patients will receive 600 mg oral gabapentin one hour before induction.
Gabapentin 400 mg group
21 patients will receive 400 mg oral gabapentin one hour before induction.
Gabapentin 400 mg capsules
21 patients will receive 400 mg oral gabapentin one hour before induction.
control group
21 patients will receive placepo one hour before induction.
Placebo
21 patients will receive placepo one hour before induction.
Interventions
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Gabapentin 600 mg capsules
21 patients will receive 600 mg oral gabapentin one hour before induction.
Gabapentin 400 mg capsules
21 patients will receive 400 mg oral gabapentin one hour before induction.
Placebo
21 patients will receive placepo one hour before induction.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. patient refusal
3. epilepsy
4. neurological or psychological conditions that impair communication.
5. current use of gabapentin, psychotropic or opioids medications.
18 Years
60 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Maged Mobarak Abdelkhalek Abdelfattah
assisstant lecturer
Locations
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Kasr Elainy Hospital , Cairo University
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Hebatallah Salah Abdelhamid, : Lecturer of anesthesia, ICU
Role: CONTACT
Facility Contacts
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References
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Badawy AA, Kasem SA, Rashwan D, Al Menesy T, Adel G, Mokhtar AM, Badawy YA. The role of Gabapentin oral solution in decreasing desflurane associated emergence agitation and delirium in children after stabismus surgery, a prospective randomized double-blind study. BMC Anesthesiol. 2018 Jun 20;18(1):73. doi: 10.1186/s12871-018-0533-5.
Other Identifiers
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gabapentin for agitation
Identifier Type: -
Identifier Source: org_study_id
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