- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03226080
GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture
17 de agosto de 2019 actualizado por: Scott Byram MD, Loyola University
Combined General and Spinal Anesthesia vs. Combined General and Spinal Anesthesia With Neuromuscular Blockade for Operative Repair of Hip Fractures
Surgical repair of hip fractures may be performed with various anesthetic techniques, but are most commonly completed under general anesthesia (GA) or neuraxial anesthesia (NA).
Numerous prospective and retrospective studies demonstrate improved morbidity and mortality when NA is used; however, many surgeons prefer the use of GA with neuromuscular blockade (NMB) due to the perception of better operative conditions.
This study aims to compare the operative conditions obtained from the use of combined GA and spinal with NMB vs. the use of GA with spinal without NMB.
84 patients will all receive a single shot spinal and GA and then will be randomized to receive either NMB or placebo.
The fracture reduction time will be measured.
Descripción general del estudio
Estado
Retirado
Intervención / Tratamiento
Descripción detallada
Eighty-four ASA I-IV patients presenting for operative repair of an unstable intertrochanteric femur fracture will be enrolled.
This will include fractures classified according to the Orthopaedic Trauma Association / Arbeitsgemeinschaft fur Osteosynthesisfragen (OTA/AO) classification system as 31A2.2,
31A2.3,
31A3.1, 31A3.2, and 31A3.3.15
After consent and upon arrival to the operating room, patients will be monitored and then sedated with midazolam, fentanyl, and ketamine as necessary per standard practice to facilitate lateral positioning.
Patients will be positioned with the operative side down for the spinal blockade.
Under sterile conditions, spinal anesthesia will be induced with 10mg (1.2mL) of hyperbaric 0.75% bupivicaine as per standard practice.
The patient will then be given a standard general anesthetic induction consisting of propofol, succinylcholine, fentanyl, and lidocaine.
The patient will be intubated and anesthesia will be maintained with desflurane in oxygen and air.
At the time of incision, the patient will be randomized to one of two groups.
The surgeon and the anesthesiologist will be blinded to the patient's randomization status.
Group 1 (NMB) will be given IV rocuronium 0.6mg/kg in a volume of 10cc.
Group 2 (placebo) will be given 10cc normal saline.
The anesthesia practitioner will test a Train of Four (TOF) and confirm a return of twitches prior to administering the study intervention.
The nerve stimulator will then be disconnected until the conclusion of the case.
Hemodynamic changes which suggest light anesthesia will be treated with additional fentanyl in 50mcg increments and/or increasing the desflurane concentration.
Any hypotension directly attributed to the anesthetic by the anesthetic practitioner will be managed using a phenylephrine bolus and/or infusion as per standard anesthetic practice.
Surgery will be performed by one of three fellowship trained orthopedic trauma surgeons, and fixation of these fractures will be with a single type of cephalomedullary implant (Synthes TFN-A, West Chester, PA).
These three surgeons employ an identical bed, patient position, and traction technique (sterile skeletal traction) for these procedures.
A percutaneous reduction will first be attempted.
If unsuccessful, an open reduction will then be pursued.
Following adequate reduction, fixation with the cephalomedullary implant will then be completed.
Once skin closure has been initiated, to reverse any NMB, sugammadex 200mg in 2ml will be given to those patients randomized to the NMB group, and 2mL normal saline for the placebo group.
At the discretion of the attending anesthesiologist, a nerve stimulator may be reapplied not less than 5 minutes after NMB reversal (or saline) is given.
Once the attending surgeon has evaluated the final radiographs, all patients will have their anesthetics discontinued and will be extubated after emergence from anesthesia.
Tipo de estudio
Intervencionista
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Illinois
-
Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
55 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- ASA I-IV Age 55 or older Scheduled for operative repair of isolated intertrochanteric hip fracture
Exclusion Criteria:
- Inability to consent/refusal Allergy to any of the study medications Multiple traumatic injuries Contraindication to neuraxial or general anesthesia Pregnancy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
Patients will be monitored and then sedated with midazolam, fentanyl, and ketamine as necessary per standard practice to facilitate lateral positioning.
Patients will be positioned with the operative side down for the spinal blockade.
Under sterile conditions, spinal anesthesia will be induced with 9mg (1.2mL) of hyperbaric 0.75% bupivacaine as per standard practice.
The patient will then be given a standard general anesthetic induction consisting of propofol, succinylcholine, fentanyl, and lidocaine.
At the time of incision, this group will be given 10cc normal saline.
Once skin closure has been initiated, 2mL normal saline will be administered.
|
Normal saline will be administered as a placebo in equal volume for the placebo group
|
|
Comparador activo: Neuromuscular Blockade
Patients will be monitored and then sedated with midazolam, fentanyl, and ketamine as necessary per standard practice to facilitate lateral positioning.
Patients will be positioned with the operative side down for the spinal blockade.
Under sterile conditions, spinal anesthesia will be induced with 9mg (1.2mL) of hyperbaric 0.75% bupivacaine as per standard practice.
The patient will then be given a standard general anesthetic induction consisting of propofol, succinylcholine, fentanyl, and lidocaine.
At the time of incision, this group will be given IV rocuronium 0.6mg/kg in a volume of 10cc.
Once skin closure has been initiated, sugammadex 200mg in 2ml will be administered.
|
The neuromuscular blockade group will receive intravenous rocuronium
The neuromuscular blockade group will receive intravenous sugammadex for reversal of residual rocuronium
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to complete reduction of the fracture
Periodo de tiempo: Measured once Post-Op Day #0 in the recovery room
|
Time necessary for complete reduction in the operating room.
|
Measured once Post-Op Day #0 in the recovery room
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Surgical Operative Conditions
Periodo de tiempo: Measured once Post-Op Day #0 in the recovery room
|
The surgeon's opinion of the operative conditions, as measured using a 4 point likert scale.
|
Measured once Post-Op Day #0 in the recovery room
|
|
Estimated Blood Loss
Periodo de tiempo: Measured once Post-Op Day #0 in the recovery room
|
Final estimated blood loss in mL for the procedure
|
Measured once Post-Op Day #0 in the recovery room
|
|
Total operating room time
Periodo de tiempo: Measured once Post-Op Day #0 in the recovery room
|
Total number of minutes spent in the operating room
|
Measured once Post-Op Day #0 in the recovery room
|
|
Time to extubation
Periodo de tiempo: Measured once Post-Op Day #0 in the recovery room
|
Total time from intubation to extubation
|
Measured once Post-Op Day #0 in the recovery room
|
|
Intraoperative fentanyl use
Periodo de tiempo: Measured once Post-Op Day #0 in the recovery room
|
Total amount (in mcg) of intravenous fentanyl used during the procedure
|
Measured once Post-Op Day #0 in the recovery room
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
- Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. doi: 10.1007/s00198-006-0172-4. Epub 2006 Sep 16.
- Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
- Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
- Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.
- Marsh JL, Slongo TF, Agel J, Broderick JS, Creevey W, DeCoster TA, Prokuski L, Sirkin MS, Ziran B, Henley B, Audige L. Fracture and dislocation classification compendium - 2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007 Nov-Dec;21(10 Suppl):S1-133. doi: 10.1097/00005131-200711101-00001.
- Chu CC, Weng SF, Chen KT, Chien CC, Shieh JP, Chen JY, Wang JJ. Propensity Score-matched Comparison of Postoperative Adverse Outcomes between Geriatric Patients Given a General or a Neuraxial Anesthetic for Hip Surgery: A Population-based Study. Anesthesiology. 2015 Jul;123(1):136-47. doi: 10.1097/ALN.0000000000000695.
- Basques BA, Bohl DD, Golinvaux NS, Samuel AM, Grauer JG. General versus spinal anaesthesia for patients aged 70 years and older with a fracture of the hip. Bone Joint J. 2015 May;97-B(5):689-95. doi: 10.1302/0301-620X.97B5.35042.
- Bulka CM, Terekhov MA, Martin BJ, Dmochowski RR, Hayes RM, Ehrenfeld JM. Nondepolarizing Neuromuscular Blocking Agents, Reversal, and Risk of Postoperative Pneumonia. Anesthesiology. 2016 Oct;125(4):647-55. doi: 10.1097/ALN.0000000000001279.
- Stewart PA, Liang SS, Li QS, Huang ML, Bilgin AB, Kim D, Phillips S. The Impact of Residual Neuromuscular Blockade, Oversedation, and Hypothermia on Adverse Respiratory Events in a Postanesthetic Care Unit: A Prospective Study of Prevalence, Predictors, and Outcomes. Anesth Analg. 2016 Oct;123(4):859-68. doi: 10.1213/ANE.0000000000001513.
- Chang CC, Lin HC, Lin HW, Lin HC. Anesthetic management and surgical site infections in total hip or knee replacement: a population-based study. Anesthesiology. 2010 Aug;113(2):279-84. doi: 10.1097/ALN.0b013e3181e2c1c3.
- Zorrilla-Vaca A, Grant MC, Mathur V, Li J, Wu CL. The Impact of Neuraxial Versus General Anesthesia on the Incidence of Postoperative Surgical Site Infections Following Knee or Hip Arthroplasty: A Meta-Analysis. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):555-63. doi: 10.1097/AAP.0000000000000437.
- Mauermann WJ, Shilling AM, Zuo Z. A comparison of neuraxial block versus general anesthesia for elective total hip replacement: a meta-analysis. Anesth Analg. 2006 Oct;103(4):1018-25. doi: 10.1213/01.ane.0000237267.75543.59.
- Mazze RI, Fujinaga M. Postdural puncture headache after continuous spinal anesthesia with 18-gauge and 20-gauge needles. Reg Anesth. 1993 Jan-Feb;18(1):47-51.
- Holmstrom B, Laugaland K, Rawal N, Hallberg S. Combined spinal epidural block versus spinal and epidural block for orthopaedic surgery. Can J Anaesth. 1993 Jul;40(7):601-6. doi: 10.1007/BF03009695.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de julio de 2017
Finalización primaria (Anticipado)
1 de agosto de 2019
Finalización del estudio (Anticipado)
1 de agosto de 2020
Fechas de registro del estudio
Enviado por primera vez
1 de mayo de 2017
Primero enviado que cumplió con los criterios de control de calidad
19 de julio de 2017
Publicado por primera vez (Actual)
21 de julio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2019
Última verificación
1 de agosto de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Heridas y Lesiones
- Lesiones en las piernas
- Fracturas Femorales
- Lesiones de cadera
- Fracturas, Hueso
- Fracturas de cadera
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Agentes neuromusculares
- Agentes neuromusculares no despolarizantes
- Agentes bloqueantes neuromusculares
- Rocuronio
Otros números de identificación del estudio
- 209397
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Anestesia General
-
Öğr. Gör. Ali GÜZELHasan Kalyoncu UniversityReclutamientoCirugía abdominal | Anestesia general | Cirugía GeneralPavo
-
University Medical Center GroningenInsel Gruppe AG, University Hospital BernTerminadoAnestesia GeneralPaíses Bajos, Suiza
-
Indonesia UniversityTerminadoPrecisión de la predicción para el tamaño único de TM de la máscara Langeal en pacientes pediátricosAnestesia generalIndonesia
-
Yonsei UniversityTerminado
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Dutch... y otros colaboradoresTerminadoFuncionamiento general | Incremental Cost-effectiveness RatioPaíses Bajos
-
Hospices Civils de LyonTerminado
-
Universitas PadjadjaranTerminado
-
Chang Gung Memorial HospitalTerminadoAnestesia GeneralTaiwán
-
Medasense Biometrics LtdTerminadoAnestesia GeneralIsrael
-
Massachusetts General HospitalDesconocidoAnestesia general | Cirugía General | Pediatría | Salida cardíaca | Anestesiología | OrtopedíaEstados Unidos
Ensayos clínicos sobre Normal saline
-
Helsinki University Central HospitalLaerdal Foundation; The Finnish Medical Association; Orion Research Foundation; Finnish...TerminadoParo cardíaco fuera del hospitalDinamarca, Finlandia
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)TerminadoObesidad | Enfermedad cardiovascular | Diabetes Mellitus, Tipo IIEstados Unidos
-
Texas Cardiac Arrhythmia Research FoundationSuspendidoArritmia ventricularEstados Unidos
-
Texas Cardiac Arrhythmia Research FoundationTerminadoFibrilación auricularCanadá, Estados Unidos
-
Ann & Robert H Lurie Children's Hospital of ChicagoRetirado
-
MemorialCare Health SystemTerminadoDuración del trabajo de parto | Segunda etapa del trabajo de parto | Hidratación intravenosa del partoEstados Unidos
-
University of MichiganRadiological Society of North AmericaTerminado
-
University of HaifaWestern Galilee Hospital-NahariyaReclutamiento
-
Superior UniversityActivo, no reclutandoCambio de personalidad duraderaPakistán
-
Virginia Commonwealth UniversityUnited States Department of DefenseRetirado