Effect of Bilateral Trans-nasal Sphenopalatine Ganglion Block on Emergence Agitation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 100
- Locations
- 1
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study solution was prepared in identical syringes by a scrub nurse who was not involved in patient management, outcome assessment, data collection, or statistical analysis. Participants, the surgeon performing the block and surgery, the attending anesthesiologist, outcome assessors, investigators, and the statistician remained blinded to treatment allocation throughout the study.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-65 years.
- •ASA physical status I-II.
- •Scheduled for elective FESS under general anesthesia.
- •Ability to provide informed consent.
Exclusion Criteria
- •ASA physical status III or higher.
- •Known allergy or contraindication to local anesthetics.
- •Coagulopathy or anticoagulant therapy.
- •Psychiatric illness or cognitive impairment affecting agitation assessment.
- •Chronic opioid use or substance abuse.
- •Pregnancy or lactation.
- •Revision nasal surgery or anatomical abnormalities preventing SPGB.
- •Intraoperative complications requiring deviation from the study protocol.