- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03647735
Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block
Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block: Patient-controlled Sedation Versus Target-controlled Infusion
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Central neuraxial block (CNB) is one of the mainstays of anaesthesia methods in various disciplines particularly orthopaedic surgeries. However the state of consciousness can potentially cause patient anxiety thus sedation is often utilized as a mean to improve patient satisfaction and increase patient acceptance of CNB.
Conventionally, the anaesthesiologist administers sedatives for the patients. Propofol is the commonly used drug for sedation due to its favourable pharmacokinetic profile, which results in fast induction, easy control of depth of sedation and rapid recovery. It can be infused by using target-controlled infusion (TCI) devices where the anaesthetists titrates propofol by setting desired target plasma and effect site concentration. However it is difficult to judge precisely patient requirements for adequate patient sedation, comfort and analgesia as patients' needs differ.
Patient-controlled sedation (PCS) is a valid option, initially adapted from post surgery patient-controlled analgesia. It allows patients to titrate sedative medication to their comfort and therefore present an option that addresses the needs of patients with strong desire to maintain sense of control during procedures.
This study was designed to compare total propofol requirement between PCS versus TCI sedation (TCIS), complications and patient satisfaction, in patients undergoing lower limb orthopaedic surgery under CNB.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malasia, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I or II.
- Aged 18-65 years.
- Elective lower limb orthopaedic surgery under CNB anticipated to last for 1.5 to 2 hours
Exclusion Criteria:
- Body Mass Index (BMI) > 30kg/m2
- Unable to cooperate (eg. mental disorders, language barrier)
- Drug abuse
- Alcoholism (chronic daily alcohol intake greater than 75 g of pure alcohol for ≥ 2 years, where 75g of alcohol = 5 cans of beer, 1 bottle of wine or half a pint of distilled spirit)
- Contraindications to the study drugs
- Pregnancy
- Significant pulmonary or cardiovascular diseases, including obstructive sleep apnoea and obesity hypoventilation syndrome
- Features of difficult airway
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Group PCS
Patients in Group PCS (patient-controlled sedation) received intravenous (IV) propofol via a patient controlled analgesia (PCA) infusion pump.
The machine was set to deliver a demand bolus dose of 0.25 mg/kg with 1-minute lockout interval, without basal infusion.The patient was instructed to press on a hand-held device as often as required, to achieve their desired level of comfort or sedation.
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Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
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Comparador activo: Group TCIS
Patients in Group TCIS (target-controlled infusion sedation) received IV propofol via a target-controlled infusion (TCI) pump, targeted at an initial effect site concentration (Cet) of 0.6 μg/ml, using the Schnider pharmacokinetic model.
Upon attainment of 0.6 μg/ml Cet, the patient's sedation level was assessed.
The Cet was increased or reduced accordingly by 0.2 μg/ml to attain an OAA/S score of 3.
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Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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total propofol requirement between PCS versus TCI sedation (TCIS)
Periodo de tiempo: Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Total propofol requirement in both groups was calculated in mg/kg/hour.
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Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient satisfaction assessed by a 10-point numerical scale
Periodo de tiempo: Within one hour after recovery from sedation
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Assessed using a 10-point verbal numerical rating scale (1 to 10), where 1 was regarded as extremely dissatisfied and 10 extremely satisfied.
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Within one hour after recovery from sedation
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Complications including incidence of hypotension, bradycardia, hypopnea, oxygen desaturation and over sedation
Periodo de tiempo: Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Documented as Yes or No for each specified complication
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Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nadia Md Nor, MMED(Anaes), Universiti Kebangsaan Malaysia Medical Centre
Publicaciones y enlaces útiles
Publicaciones Generales
- Wahlen BM, Kilian M, Schuster F, Muellenbach R, Roewer N, Kranke P. Patient-controlled versus continuous anesthesiologist-controlled sedation using propofol during regional anesthesia in orthopedic procedures--a pilot study. Expert Opin Pharmacother. 2008 Nov;9(16):2733-9. doi: 10.1517/14656566.9.16.2733.
- Ekin A, Donmez F, Taspinar V, Dikmen B. Patient-controlled sedation in orthopedic surgery under regional anesthesia: a new approach in procedural sedation. Braz J Anesthesiol. 2013 Sep-Oct;63(5):410-4. doi: 10.1016/j.bjan.2012.07.012.
- Singh T, Ravishankar M. Conscious sedation with propofol for surgeries under spinal anaesthesia: anaesthesiologist versus patient controlled. J Anaesthesiol Clin Pharmacol. 21:169-173, 2005.
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
- FF-2017-265
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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