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Emergence agitation is a postanesthetic phenomenon that develops in the early phase of recovery from general anesthesia, and is characterized by agitation, disorientation, confusion, and possible violent behavior. Emergence agitation can cause serious events such as self-extubation, bleeding, catheter removal and even falling out of the bed leading to severe injuries . Furthermore, it may lead to injuries to health care providers and increase the demand on human resources.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin 600 mg group | Active Comparator | 21 patients will receive 600 mg oral gabapentin one hour before induction. |
|
| Gabapentin 400 mg group | Active Comparator | 21 patients will receive 400 mg oral gabapentin one hour before induction. |
|
| control group | Placebo Comparator | 21 patients will receive placepo one hour before induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin 600 mg capsules | Drug | 21 patients will receive 600 mg oral gabapentin one hour before induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asessment of emergence agitation | Asessment of emergence agitation by Richmond Agitation Sedation Scale(RASS) (score +1 or more) maximum value is +4 (combative) andminimum value is - (unarousable) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of emergence | The time in minutes from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command | through study completion, an average of 1 year |
| Duration of Post Anesthesia Care Unit (PACU)stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| maged mobarak mobarak, assisstant lecturer | Contact | +0201010282650 | magedmubark98@gmail.com | |
| Hebatallah Salah Abdelhamid, : Lecturer of anesthesia, ICU | Contact | +201004507530 | drhebasalah593@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Elainy Hospital , Cairo University | Cairo | Cairo Governorate | 11956 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29925328 | Background | 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. |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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Patients will be randomly allocated (using sealed opaque numbered envelopes indicating the group of each patient, carried out by an independent anesthesiologist) into one of three groups :
| Gabapentin 400 mg capsules | Drug | 21 patients will receive 400 mg oral gabapentin one hour before induction. |
|
| Placebo | Drug | 21 patients will receive placepo one hour before induction. |
|
the time in minutes from arrival to Post Anesthesia Care Unit (PACU) to discharge to ward
| through study completion, an average of 1 year |
| Number of patients had Postoperative pain | Postoperative pain through Numerical Rating Scale (0 represents no pain and 10 represents worst possible pain) | through study completion, an average of 1 year |
| Number of patients required postoperative opioids and total dose. | through study completion, an average of 1 year |
| Number of patients had postoperative nausea and vomiting (PONV). | through study completion, an average of 1 year |
| 1. Heart rate | heart rate in beat per minute (bpm) will be recorded every 5 minutes till the end of operation. | through study completion, an average of 1 year |
| systolic, diastolic and mean arterial blood pressure | systolic, diastolic and mean arterial blood pressure in millimeter of mercury (mmHg) will be recorded every 5 minutes till the end of operation. | through study completion, an average of 1 year |
| Oxygen saturation | Oxygen saturation in percentage will be recorded every 5 minutes till the end of operation. | through study completion, an average of 1 year |
| Duration of extubation | the time in minutes from discontinuation of the anesthetic to removal of endotracheal tube | through study completion, an average of 1 year |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |