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NCT Number: NCT07645521

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

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.

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Key information

Conditions

Chronic Rhinosinusitis (CRS) Confusion Delirium Emergence Agitation Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilateral Trans-nasal Sphenopalatine Ganglion Block

Procedure

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

Other names: Endoscopic Sphenopalatine Ganglion Block, SPGB

Sham Trans-nasal Injection

Procedure

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

Other names: Placebo Injection, Sham Procedure, Sham Sphenopalatine Ganglion Block

Primary outcomes

  1. Incidence of Emergence Agitation

    Time frame: 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 outcomes

  1. Postoperative Pain Scores

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

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

  2. Postoperative Fentanyl Consumption

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

    Total postoperative fentanyl requirement administered for rescue analgesia.

  3. Mean Arterial Blood Pressure

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

    Intraoperative and postoperative mean arterial blood pressure measurements.

  4. Heart Rate

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

    Intraoperative and postoperative heart rate measurements.

  5. Incidence of Postoperative Nausea and Vomiting

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

    Occurrence of postoperative nausea and/or vomiting.

  6. Adverse Events

    Time frame: 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.

  7. Duration of Surgery

    Time frame: During surgery

    Total operative time measured from surgical incision to completion of surgery.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effect of Bilateral Trans-nasal Sphenopalatine Ganglion Block on Emergence Agitation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial

Acronym: SPGB-EA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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