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

Last updated: March 19, 2025
Sponsor: Cairo University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Manic Disorders

Dementia

Williams Syndrome

Treatment

Gabapentin 400 mg capsules

Placebo

Gabapentin 600 mg capsules

Clinical Study ID

NCT06887998
gabapentin for agitation
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • All patients (male/female, American Society of Anesthesiologists physical statusI-II, age: 18-60 years) undergoing elective nasal surgery will be eligible for thestudy.

Exclusion

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.

Study Design

Total Participants: 63
Treatment Group(s): 3
Primary Treatment: Gabapentin 400 mg capsules
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Kasr Elainy Hospital , Cairo University

    Cairo, 11956
    Egypt

    Site Not Available

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