Clinical trial NCT06887998: The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Emergence Agitation
Keywords: emergence agitation
gabapentin
nasal surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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:

1. hypersensitivity to gabapentin
2. patient refusal
3. epilepsy
4. neurological or psychological conditions that impair communication.
5. current use of gabapentin, psychotropic or opioids medications.

Primary outcomes:
measure: Asessment of emergence agitation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Duration of emergence
timeFrame: through study completion, an average of 1 year
measure: Duration of Post Anesthesia Care Unit (PACU)stay
timeFrame: through study completion, an average of 1 year
measure: Number of patients had Postoperative pain
timeFrame: through study completion, an average of 1 year
measure: Number of patients required postoperative opioids and total dose.
timeFrame: through study completion, an average of 1 year
measure: Number of patients had postoperative nausea and vomiting (PONV).
timeFrame: through study completion, an average of 1 year
measure: 1. Heart rate
timeFrame: through study completion, an average of 1 year
measure: systolic, diastolic and mean arterial blood pressure
timeFrame: through study completion, an average of 1 year
measure: Oxygen saturation
timeFrame: through study completion, an average of 1 year
measure: Duration of extubation
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Elainy Hospital , Cairo University
Study officials:
References:
citation: 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.