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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.
Phase 3 trial testing Gabapentin 600 mg capsules in Emergence Agitation in 63 participants. Not yet recruiting.
1 February 2026
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 63 |
| Start date | 1 March 2025 |
| Primary completion | 1 February 2026 |
| Estimated completion | 1 March 2026 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Gabapentin 600 mg capsules — full drug profile →
- Gabapentin 400 mg capsules — full drug profile →
- Placebo
Conditions studied
- Emergence Agitation — all drugs for Emergence Agitation →
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.
-
Asessment of emergence agitation
Time frame: through study completion, an average of 1 year
Asessment of emergence agitation by Richmond Agitation Sedation Scale(RASS) (score +1 or more) maximum value is +4 (combative) andminimum value is - (unarousable)
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.
Verify or expand the search:
- PubMed search for NCT06887998
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Emergence Agitation
Currently open trials in the same condition.
- NCT07523438 — Effect of Intranasal Dexmedetomidine on the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery · NA · recruiting
- NCT07389135 — Heart Rate Variability and Anxiety as Predictors of Emergence Agitation After Septorhinoplasty · recruiting
- NCT07348497 — Effects of Preoperative Education on Anxiety and Emergence Agitation · NA · active not recruiting
- NCT07253428 — Emergence Agitation · NA · active not recruiting
- NCT07435675 — Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric · NA · recruiting
Other Cairo University trials
Trials by the same sponsor.
- NCT04155528 — Effect of Music Therapy on Postoperative Health Outcomes · NA · not yet recruiting
- NCT07363239 — CBCT-Based Safety Distance for Implant Placement Near the Inferior Alveolar Canal · not yet recruiting
- NCT07374575 — Egyptian Dental Professionals' Perspectives on the Oral Microbiome and Exosomes · not yet recruiting
- NCT07381153 — In-Vitro Cytotoxicity Assessment of INOX (Nanoksa G Plus) Polymer Discs · not yet recruiting
- NCT07375394 — 3D-Printed Extraoral Camera for Standardized Dental Photography · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06887998 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cairo University
- Last refreshed: 19 March 2025
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.
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