- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07643298
Effect of Lidocaine Through Gastric Tube on PONV
Effect of Lidocaine Applied Via Nasogastric Tube on Postoperative Nausea and Vomiting in Obese Patients Undergoing Bariatric Surgery
The goal of this clinical trial is to learn if intragastric administration of lidocaine can reduce postoperative nausea and vomiting in obese patients undergoing laparoscopic sleeve gastrectomy. The main question it aims to answer is:
Does administering 0.5% lidocaine via an orogastric tube reduce the incidence of postoperative nausea and vomiting (PONV) in the post-anesthesia care unit and within the first 24 hours after surgery compared to a placebo (normal saline)?
Researchers will compare the Lidocaine Group to the Placebo Group to see if the intervention lowers the PONV incidence.
Participants will:
- Receive the assigned study solution (either 0.5% lidocaine 20ml or normal saline 20ml) through an orogastric tube upon surgery completion and before extubation.
- Have their gastric tube clamped for 5 minutes to ensure mucosal exposure before removal.
- Undergo standardized total intravenous anesthesia and perioperative management according to the study protocol.
- Be assessed for nausea, vomiting, and other outcomes at specified time points postoperatively in the recovery room and at 6, 12, and 24 hours.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Postoperative nausea and vomiting (PONV) is a common complication following bariatric surgery, with incidence rates reaching up to 30-80%. In bariatric surgical patients, the burden of PONV is particularly high due to multiple risk factors, including surgical trauma to upper GI system, frequent opioid use, increased intra-abdominal pressure, altered gastric anatomy, and heightened sensitivity of gastrointestinal reflex pathways. Effective prevention and treatment of PONV in this population therefore represents a major clinical priority.
Current prophylactic strategies rely primarily on pharmacological agents such as serotonin (5-HT3) receptor antagonists, corticosteroids, dopamine antagonists, and multimodal combinations. Despite these measures, the incidence of breakthrough PONV remains significant, underscoring the need for additional safe, effective, and inexpensive interventions.
Lidocaine, traditionally used as a local anesthetic and antiarrhythmic, has gained attention in perioperative medicine for its systemic anti-inflammatory, analgesic, and opioid-sparing effects when administered intravenously. Evidence suggests that perioperative lidocaine can improve gastrointestinal motility, reduce visceral hypersensitivity, and facilitate earlier return of bowel function. These properties raise the possibility that lidocaine may also influence nausea and vomiting pathways by attenuating vagal afferent signaling, reducing local gastric irritation, and dampening inflammatory responses within the gastrointestinal mucosa.
Delivering lidocaine directly into the gastric cavity via an orogastric (OG) tube represents a novel and pragmatic approach. Unlike intravenous administration, intragastric instillation allows targeted mucosal exposure, potentially reducing afferent vagal stimulation that triggers nausea and vomiting. This method is technically simple, inexpensive, and feasible within the routine workflow of bariatric surgery, as OG tubes are already placed for intraoperative management.
This study aims to evaluate whether the administration of lidocaine via nasogastric tube can reduce the incidence of postoperative nausea and vomiting (PONV) in patients undergoing bariatric surgery. If effective, local lidocaine administration may serve as a simple, low-cost, and readily adoptable strategy to improve postoperative outcomes in bariatric surgery patients. This approach could expand the multimodal anesthesia regimen and optimize the enhanced recovery after surgery (ERAS) pathway for bariatric procedures.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Siying He
- Número de teléfono: +86 18209610221
- Correo electrónico: 1342850868@qq.com
Ubicaciones de estudio
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Ningxia
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Yinchuan, Ningxia, Porcelana, 750000
- Reclutamiento
- General Hospital of Ningxia Medical University
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Contacto:
- General Hospital of Ningxia Medical University
- Número de teléfono: +86-0951-4091488
- Correo electrónico: 1342850868@qq.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged between 18 and 65 years old;
- American Society of Anesthesiologists (ASA) physical status classification II - III;
- Planned to undergo primary elective laparoscopic sleeve gastrectomy with general anesthesia;
- Capable of giving informed consent.
Exclusion Criteria:
- Known allergy, hypersensitivity or contraindication to lidocaine or amide - type local anesthetics;
- Previous significant liver or kidney dysfunction (e.g., ALT/AST > 3 times the upper limit of normal, GFR < 30 mL/min);
- History of epilepsy, cardiac conduction abnormalities or previous diagnosis of malignant hyperthermia;
- Pregnancy or lactation;
- Patients who received systemic lidocaine treatment during the operation;
- History of severe postoperative nausea and vomiting (PONV) or motion sickness, requiring multiple prophylactic medications;
- Emergency or revision bariatric surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Lidocaine
Lidocaine is administered via a gastric tube.
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Upon completion of the surgery and before extubation, 20 ml of 0.5% lidocaine should be administered through the pre - inserted orogastric tube.
The gastric tube should be clamped for 5 minutes to ensure sufficient mucosal exposure, and then removed before extubation.
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Experimental: Normal Saline
Administer normal saline through the gastric tube.
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Before extubation after the surgery is completed, administer 20 ml of normal saline through the pre - inserted orogastric tube.
Clamp the gastric tube for 5 minutes to ensure sufficient mucosal exposure, and then remove the tube before extubation.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The incidence of postoperative nausea and vomiting (PONV) in the post - anesthesia care unit and within 24 hours after surgery.
Periodo de tiempo: Within 24 hours after the operation
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Within 24 hours after the operation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Degree of postoperative nausea and vomiting
Periodo de tiempo: 6 hours, 12 hours, and 24 hours after surgery
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The severity of nausea and vomiting was assessed using the Numerical Rating Scale at 6 hours, 12 hours, and 24 hours after surgery, respectively.
A score of 0 indicated no nausea or vomiting, and a score of 10 indicated the most severe nausea or vomiting.
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6 hours, 12 hours, and 24 hours after surgery
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Incidence rates of simple vomiting, simple nausea, and their combination during the postoperative anesthesia recovery room period and within 24 hours after surgery.
Periodo de tiempo: Within 24 hours after the operation
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Within 24 hours after the operation
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Use rescue antiemetics
Periodo de tiempo: Within 24 hours after surgery.
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Use of emergency antiemetic drugs and time nodes after surgery.
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Within 24 hours after surgery.
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Opioid use within 24 hours after surgery
Periodo de tiempo: 24 hours after surgery
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The amount of opioids used 24 hours after surgery.
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24 hours after surgery
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Time of first tolerable oral intake
Periodo de tiempo: Within 72 hours after surgery.
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The time of the first oral tolerance to eating after surgery
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Within 72 hours after surgery.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
- Complicaciones Postoperatorias
- Procesos Patológicos
- Signos y Síntomas Digestivos
- Vómitos
- Náuseas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Náuseas y vómitos postoperatorios
- Químicos orgánicos
- Preparaciones farmacéuticas
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Acetanilidas
- Soluciones cristaloides
- Soluciones isotónicas
- Soluciones
- Lidocaína
- Solución salina
Otros números de identificación del estudio
- Siying He-2026-01
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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