About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All patients (male/female, American Society of Anesthesiologists physical status I-II, age: 18-60 years) undergoing elective nasal surgery will be eligible for the study.
Disqualifiers
hypersensitivity to gabapentin
patient refusal
epilepsy
neurological or psychological conditions that impair communication.
Trial design
Parallel
Treatments tested in this trial
Gabapentin 600 mg capsules
Drug21 patients will receive 600 mg oral gabapentin one hour before induction.
Gabapentin 400 mg capsules
Drug21 patients will receive 400 mg oral gabapentin one hour before induction.
Placebo
Drug21 patients will receive placepo one hour before induction.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Duration of emergence
The time in minutes from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command
Duration of Post Anesthesia Care Unit (PACU)stay
the time in minutes from arrival to Post Anesthesia Care Unit (PACU) to discharge to ward
Number of patients had Postoperative pain
Postoperative pain through Numerical Rating Scale (0 represents no pain and 10 represents worst possible pain)
Number of patients required postoperative opioids and total dose.
Sponsors and contacts
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