Chronic Rhinosinusitis (CRS), Emergence Agitation
Conditions
Keywords
Functional Endoscopic Sinus Surgery, FESS, Sphenopalatine Ganglion Block, SPGB, Trans-nasal Sphenopalatine Ganglion Block, Emergence Agitation, Randomized Controlled Trial, Postoperative Pain, Sinonasal Surgery
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.
Interventions
PROCEDUREBilateral 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.
PROCEDURESham Trans-nasal Injection
Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL of normal saline per side.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Emergence Agitation | first 30 minutes in the post-anesthesia care unit (PACU). | Incidence of emergence agitation, defined as a Richmond Agitation-Sedation Scale (RASS) score ≥ +2 at any time during the first 30 minutes in the post-anesthesia care unit (PACU). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | first 30 minutes in the post-anesthesia care unit (PACU) | Pain intensity assessed using the Visual Analog Scale (VAS). |
| Postoperative Fentanyl Consumption | first 30 minutes in the post-anesthesia care unit (PACU) | Total postoperative fentanyl requirement administered for rescue analgesia. |
| Mean Arterial Blood Pressure | From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU) | Intraoperative and postoperative mean arterial blood pressure measurements. |
| Heart Rate | From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU) | Intraoperative and postoperative heart rate measurements. |
| Incidence of Postoperative Nausea and Vomiting | first 30 minutes in the post-anesthesia care unit (PACU) | Occurrence of postoperative nausea and/or vomiting. |
| Adverse Events | From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU) | Procedure-related complications including epistaxis, local anesthetic systemic toxicity, diplopia or visual symptoms, palatal numbness, and other adverse events. |
| Duration of Surgery | During surgery | Total operative time measured from surgical incision to completion of surgery. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAmir Mostafa Shabana, MD
Faculty of Medicine, Mansoura University, Mansoura, Egypt
Outcome results
None listed