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Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery

Post Operative Pain · Emergence Agitation · Functional Endoscopic Sinus Surgery

LO ESENCIAL

De qué trata este estudio

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Tipo de estudio
De intervención
Fase
Fase 4
Rango de edad
18 años - 60 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
60 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This prospective, randomized, double-blind, controlled trial will compare the efficacy and safety of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided bilateral sphenopalatine ganglion block for adult patients (18-60 years, ASA I-II) undergoing elective functional endoscopic sinus surgery (FESS) under general anesthesia. Participants will be randomly allocated in a 1:1:1 ratio to receive bupivacaine alone, bupivacaine plus dexmedetomidine, or bupivacaine plus dexamethasone. The study will assess postoperative pain scores, duration of analgesia, total analgesic consumption, and intraoperative hemodynamic parameters, in addition to adverse effects.

Leer la descripción completa

Background: Postoperative pain after functional endoscopic sinus surgery (FESS) is often significant, and conventional management relies on opioids and NSAIDs, which carry potential side effects. Ultrasound-guided sphenopalatine ganglion block (SPGB) with bupivacaine provides regional analgesia, but its duration may be insufficient. Dexmedetomidine and dexamethasone are adjuvants known to prolong analgesia and reduce analgesic requirements, yet direct comparative evidence for ultrasound-guided SPGB in FESS is limited.

Design: Prospective, randomized, double-blind, controlled clinical trial conducted at the ENT department, Sohag University Hospital. Eligible patients (age 18-60 years, ASA I-II, elective FESS under general anesthesia) who provide written informed consent will be randomized 1:1:1 using a computer-generated sequence, with allocation concealed in sequentially numbered, opaque, sealed envelopes. Patients with allergy to local anesthetics, coagulopathy or anticoagulant use, anatomical nasal deformities obstructing access, or who refuse participation will be excluded.

Interventions: All patients will receive ultrasound-guided bilateral SPGB with a total volume of 10 mL (5 mL per side) after induction of general anesthesia.

  • Group A (control): 8 mL bupivacaine 0.5% plus 2 mL normal saline.
  • Group B: 8 mL bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline to 2 mL.
  • Group C: 8 mL bupivacaine 0.5% plus dexamethasone 8 mg (2 mL).

Patients, anesthesiologists responsible for intraoperative and postoperative assessment, surgeons, and data analysts will be blinded to group allocation.

Anesthetic technique: General anesthesia will be induced with propofol 2.5 mg/kg and fentanyl 1 µg/kg, and intubation facilitated with atracurium 0.5 mg/kg. Anesthesia will be maintained with isoflurane in oxygen and atracurium boluses, with mechanical ventilation to keep end-tidal CO2 at 35-45 mmHg.

Outcomes: Postoperative pain scores, duration of analgesia, total analgesic consumption, intraoperative hemodynamic measurements, and adverse effects.

¿Quién podría participar?

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Inclusion Criteria:

  • Age 18-60 years.
  • Elective FESS under general anesthesia.
  • ASA Physical Status I-II

Exclusion Criteria:

  • Allergy to local anesthetics
  • Coagulopathy or use of anticoagulants
  • Anatomical nasal deformities obstructing access
  • Patient refusal
Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento cuádruple
Group A: Bupivacaine

Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus 2 mL of normal saline, giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia.

Drug: Bupivacaine & normal saline

Group B: Bupivacaine + Dexmedetomidine

Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline to 2 mL, giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia.

Drug: Dexmedetomidine & Bupivacaine.

Group C: Bupivacaine + Dexamethasone

Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexamethasone 8 mg (2 mL), giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia.

Drug: Dexamethasone & Bupivacaine.

Bupivacaine & normal saline DRUG

2 mL of normal saline 0.9% added to bupivacaine 0.5% (8 mL) in the sphenopalatine ganglion block to maintain a total volume of 10 mL (5 mL per side) and ensure blinding.

Dexmedetomidine & Bupivacaine. DRUG

Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline 0.9% to a volume of 2 mL, giving a total volume of 10 mL (5 mL per side)

Dexamethasone & Bupivacaine. DRUG

Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexamethasone 8 mg (2 mL), giving a total volume of 10 mL (5 mL per side)

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Postoperative Pain Intensity Assessed by the Visual Analogue Scale (VAS)

Plazo: At PACU arrival and at 2, 4, 6, 12, and 24 hours postoperatively

Postoperative pain intensity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be compared among the three study groups.Unit of measure : score on a scale

Medidas secundarias

Time to First Rescue Analgesia

Plazo: From the end of surgery until the first rescue analgesic dose, within the first 24 hours postoperatively.

The time from the end of surgery to the first postoperative rescue analgesic request or administration. Unit of measure: minutes.

Incidence of Emergence Agitation

Plazo: During emergence from general anesthesia and at PACU arrival

Emergence agitation is defined as a Richmond Agitation-Sedation Scale (RASS) score of +1 or higher. The number of participants with emergence agitation will be reported. Unit of measure: number of participants.

Intraoperative Mean Arterial Pressure

Plazo: From baseline assessment before induction of general anesthesia until the end of surgery

Mean arterial pressure (MAP) will be recorded at baseline, after induction of general anesthesia, and every 10 minutes intraoperatively until the end of surgery. Unit of measure: mmHg.

Intraoperative Heart Rate

Plazo: From baseline before induction of general anesthesia until the end of surgery.

Heart rate (HR) will be recorded at baseline, after induction of general anesthesia, and every 10 minutes intraoperatively until the end of surgery. Unit of measure: beats per minute.

Number of Postoperative Rescue Analgesic Doses

Plazo: First 24 hours postoperatively

The total number of postoperative rescue analgesic doses administered, regardless of drug type, during the first 24 hours after surgery.Unit of measure: number of doses

El registro no indica resultados publicados.

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Centros de investigación (1)

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1 centros

Sohag university hospitalSohag, Sohag Governorate, EgyptEstado desconocido

Equipo y fechas

Patrocinador principal
Sohag University
Inicio del estudio
2026-11 Estimado
Finalización primaria
2027-05 Estimado
Finalización del estudio
2027-05 Estimado
Primera publicación
2 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Nardin Ehab Halim, M.B.B.ChCONTACTnardinehab12@gmail.com01012631360
Título oficial del estudio

Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block in Patients Undergoing Functional Endoscopic Sinus Surgery

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026