The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gabapentin 600 mg capsules, Gabapentin 400 mg capsules, Placebo.
- Who it may be relevant to
- Registry conditions: Emergence Agitation. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Two Different Doses of Oral Gabapentin on Sevoflurane-associated Emergence Agitation and Delirium in Adult Patients After Nasal Surgery. A Prospective Controlled, Randomized, Double-blinded Study.
Overview
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.
Interventions
- Drug Gabapentin 600 mg capsules
21 patients will receive 600 mg oral gabapentin one hour before induction. - Drug Gabapentin 400 mg capsules
21 patients will receive 400 mg oral gabapentin one hour before induction. - Drug Placebo
21 patients will receive placepo one hour before induction.
Primary outcome measures
- Asessment of emergence agitation [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (9)
- Duration of emergence [Time frame: through study completion, an average of 1 year]
- Duration of Post Anesthesia Care Unit (PACU)stay [Time frame: through study completion, an average of 1 year]
- Number of patients had Postoperative pain [Time frame: through study completion, an average of 1 year]
- Number of patients required postoperative opioids and total dose. [Time frame: through study completion, an average of 1 year]
- Number of patients had postoperative nausea and vomiting (PONV). [Time frame: through study completion, an average of 1 year]
- 1. Heart rate [Time frame: through study completion, an average of 1 year]
- systolic, diastolic and mean arterial blood pressure [Time frame: through study completion, an average of 1 year]
- Oxygen saturation [Time frame: through study completion, an average of 1 year]
- Duration of extubation [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- hypersensitivity to gabapentin
- patient refusal
- epilepsy
- neurological or psychological conditions that impair communication.
- current use of gabapentin, psychotropic or opioids medications.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Kasr Elainy Hospital , Cairo University — Cairo
Publications
- 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. PMID 29925328
Identifiers
NCT: NCT06887998 · gabapentin for agitation