Ácido tranexámico nebulizado versus intravenoso sobre la calidad del campo quirúrgico en pacientes sometidos a cirugías endoscópicas de los senos nasales
Efecto del ácido tranexámico nebulizado preoperatorio versus el intravenoso sobre la calidad del campo quirúrgico en pacientes sometidos a cirugías endoscópicas de los senos nasales: un estudio comparativo controlado aleatorio
Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.
Good surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.
Recent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.
The purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egipto
- Faculty of Medicine, Cairo University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age between 18 and 60 years.
- American Society of Anesthesiologists (ASA) class I and II patients.
- Endoscopic sinus surgeries under general anesthesia.
Exclusion Criteria:
- Patient's refusal.
- American Society of Anesthesiologists (ASA) class III or IV patients.
- Underlying uncontrolled hypertension.
- Known history bleeding disorder.
- Patients on anticoagulant therapy.
- Allergy to any of the drugs utilized in this study.
- History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery.
- Inadvertent intra-operative vascular injury.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Nebulized group
patients will receive nebulized tranexamic acid |
patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline. |
|
Comparador activo: Intravenous group
patients will receive intravenous tranexamic acid |
patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The mean Wormald intraoperative surgical field grading
Periodo de tiempo: 5 hours
|
The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly |
5 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total blood loss
Periodo de tiempo: 5 hours
|
calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field |
5 hours
|
|
Bleeding rate
Periodo de tiempo: 5 hours
|
calculated as the total blood loss divided by the surgical time |
5 hours
|
|
Operation time
Periodo de tiempo: 5 hours
|
Time starting from induction of anesthesia till completion of the surgical procedure |
5 hours
|
|
Postoperative complications
Periodo de tiempo: 24 hours
|
nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism |
24 hours
|
|
postoperative nasal bleeding
Periodo de tiempo: 48 hours
|
Incidence of postoperative nasal bleeding |
48 hours
|
|
postoperative intervention
Periodo de tiempo: 48 hours
|
Incidence of the need for postoperative intervention to control nasal bleeding |
48 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Kareem MA Nawwar, M.D., Cairo University
- Silla de estudio: Nevan M Abbas Elmekawy, M.D., Cairo University
- Director de estudio: Tamer M Khair, M.D., Cairo University
- Investigador principal: Nadia E M Gaballah, M.Sc., Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- MD-206-2024
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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