Trans-nasal Sphenopalatine Ganglion Block for Prevention of Emergence Agitation Following Functional Endoscopic Sinus Surgery
NCT07645521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-06-12
Summary
This randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic Sinus Surgery (FESS) compared with placebo. Secondary objectives include evaluation of postoperative pain, postoperative opioid consumption, hemodynamic parameters, postoperative nausea and vomiting, and adverse events.
Conditions
- Chronic Rhinosinusitis (CRS)
- Emergence Agitation
Interventions
- PROCEDURE
-
Bilateral Trans-nasal Sphenopalatine Ganglion Block
Bilateral trans-nasal sphenopalatine ganglion block performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side.
- PROCEDURE
-
Sham Trans-nasal Injection
Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL of normal saline per side.
Sponsors & Collaborators
-
Mansoura University
lead OTHER
Principal Investigators
-
Amir Mostafa Shabana, MD · Faculty of Medicine, Mansoura University, Mansoura, Egypt
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-05
- Primary Completion
- 2026-02-07
- Completion
- 2026-04-13
Countries
- Egypt
Study Locations
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