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Clinical Trials in Egypt / NCT06887998
Starting soon Phase 3

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

NCT06887998 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2025-03
Last updated
2025-03-21

Condition(s) studied

Emergence Agitation

Investigational drug(s) / intervention(s)

Gabapentin 600 mg capsules →Gabapentin 400 mg capsules →Placebo

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

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

Placebo: 21 patients will receive placepo one hour before induction.

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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kasr Elainy Hospital , Cairo University Cairo Cairo Governorate

More Cairo University trials in Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06887998 on ClinicalTrials.gov ↗ ← All trials in Egypt