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

NCT06887998 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-03-21

No results posted yet for this 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.

Conditions

  • Emergence Agitation

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-02-28
Completion
2026-03-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06887998 on ClinicalTrials.gov