Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

Study Overview
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Brief Summary
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To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.

Detailed Description
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Emergence agitation (EA) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are promising options for EA.

Official Title
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The Effect of Intramuscular Dexmedetomidine Versus Oral Gabapentin Premedication on the Emergence Agitation After Rhinoplasty. A Prospective, Randomized, Double-blind Controlled Trial.

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists grade I or II. Sex: Both sexes. Age between 18 and 40 years. Patients scheduled for rhinoplasty under general anesthesia Exclusion Criteria: Declining to give written informed consent. History of allergy to the medications used in the study. history of cardiovascular diseases including bradycardia, heart block, and hypertension. History of chest problems including bronchial asthma. Had a history of drug or alcohol abuse. Taking opioids or sedative medications. Inability to communicate with patients to evaluate postoperative pain. Hepatic or renal failure. Psychiatric disorders with antipsychotics or antidepressants. Bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The participants will not receive premedication | |
| Active Comparator: Dexmedetomidine<br>The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward | Drug: Dexmedetomidine<br>* The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward.<br>|
| Active Comparator: Gabapentin<br>The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward | Drug: Gabapentin<br>* The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergence agitation (EA) | in the form of Riker Sedation-Agitation Scale (where 1 = unarousable and 7 = dangerous agitation with score ≥5 considered EA). | During first hour of recovery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain in the form of visual analog scale | (VAS, 0=no pain; 10=worst possible pain) | every 4 hours for 12 hours | 
| Incidence of the common adverse effects | nausea and vomiting, dizziness, and headache | at 12 hours |