Trans-nasal Sphenopalatine Ganglion Block for Prevention of Emergence Agitation Following Functional Endoscopic Sinus Surgery

Mansoura University100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Chronic Rhinosinusitis (CRS)Emergence Agitation

Interventions

Bilateral Trans-nasal Sphenopalatine Ganglion BlockPROCEDURE

Bilateral trans-nasal sphenopalatine ganglion block performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side.

Sham Trans-nasal InjectionPROCEDURE

Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL of normal saline per side.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Incidence of Emergence Agitation

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).

Time frame: first 30 minutes in the post-anesthesia care unit (PACU).

Secondary Outcomes

Postoperative Pain Scores

Pain intensity assessed using the Visual Analog Scale (VAS).

Time frame: first 30 minutes in the post-anesthesia care unit (PACU)

Postoperative Fentanyl Consumption

Total postoperative fentanyl requirement administered for rescue analgesia.

Time frame: first 30 minutes in the post-anesthesia care unit (PACU)

Mean Arterial Blood Pressure

Intraoperative and postoperative mean arterial blood pressure measurements.

Time frame: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)

Heart Rate

Intraoperative and postoperative heart rate measurements.

Time frame: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)

Incidence of Postoperative Nausea and Vomiting

Occurrence of postoperative nausea and/or vomiting.

Time frame: first 30 minutes in the post-anesthesia care unit (PACU)

Adverse Events

Procedure-related complications including epistaxis, local anesthetic systemic toxicity, diplopia or visual symptoms, palatal numbness, and other adverse events.

Data from ClinicalTrials.gov

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