The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 3

Conditions: Emergence Agitation

Treatments: Drug: Gabapentin 600 mg capsules; Drug: Gabapentin 400 mg capsules; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06887998

gabapentin for agitation

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 3 patient groups, including a placebo group

Gabapentin 600 mg group

Active Comparator group

Description:

21 patients will receive 600 mg oral gabapentin one hour before induction.

Treatment:

Drug: Gabapentin 600 mg capsules

Gabapentin 400 mg group

Active Comparator group

Description:

21 patients will receive 400 mg oral gabapentin one hour before induction.

Treatment:

Drug: Gabapentin 400 mg capsules

control group

Placebo Comparator group

Description:

21 patients will receive placepo one hour before induction.

Treatment:

Drug: Placebo