Anesthesia
Conditions
Brief summary
To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.
Detailed description
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.
Interventions
DRUGDexmedetomidine
The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward.
DRUGGabapentin
The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| emergence agitation (EA) | During first hour of recovery. | in the form of Riker Sedation-Agitation Scale (where 1 = unarousable and 7 = dangerous agitation with score ≥5 considered EA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain in the form of visual analog scale | every 4 hours for 12 hours | (VAS, 0=no pain; 10=worst possible pain) |
| Incidence of the common adverse effects | at 12 hours | nausea and vomiting, dizziness, and headache |
Countries
Egypt
Outcome results
None listed