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NCT06887998

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.

Not yet recruiting Phase 3 Last updated 19 March 2025
What this trial tests

Phase 3 trial testing Gabapentin 600 mg capsules in Emergence Agitation in 63 participants. Not yet recruiting.

Timeline
1 March 2025
Primary endpoint
1 February 2026
1 March 2026

Quick facts

Lead sponsorCairo University
PhasePhase 3
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment63
Start date1 March 2025
Primary completion1 February 2026
Estimated completion1 March 2026
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Cairo University

Who can join

Adults 18 to 60, any sex, with Emergence Agitation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Emergence Agitation

Currently open trials in the same condition.

Other Cairo University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06887998.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing