- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00544947
Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids for Caesarean Section
Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids: a Comparison Between Diamorphine and Fentanyl Combined With Postoperative Morphine PCA Using a Carbon Dioxide Tension and Pulse Oximetry Sensor (TOSCA)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Method:
We will use transcutaneous carbon dioxide tension as our primary outcome measure of respiratory depression. Secondary outcome measures will be the oxygen-saturation, the respiratory rare, neurological status assessed by Glasgow Coma Scale (GCS) and the need for administration of naloxone and/or active airway management.
PtCO2 and SpO2 will be measured transcutaneously using the Linde TOSCA 500 Monitoring System, which is a relatively new miniaturized single sensor, that is applied to the earlobe.
There will be 2 study groups.
Group D will be patients at Princess Royal Maternity Hospital in Glasgow, where supplementation with intrathecal diamorphine 300mcg is the current anaesthetic technique of choice.
Group F will be patients at the Queen Mother's Maternity Hospital in Glasgow, where supplementation with intrathecal fentanyl 15mcg plus post-operative morphine PCA is the current anaesthetic technique of choice for elective caesarean section.
Additional postoperative Analgesia will be given as per local guidelines.
We will recruit 40 patients to each group.
Patients will receive verbal and written information prior to written consent before being included.
Information Gathering:
The TOSCA monitor will be connected in recovery following the end of caesarean section (with PCA connection at QMMH). Monitoring will be continuous until 0800hrs the following morning giving approx. 20 hours data for each patient.
Data will then be downloaded to a database for subsequent analysis. We will also note the total dose of morphine used in each patient and any complications that occurred or interventions carried out.
We plan to recruit an SHO on each site to help with information gathering.
Ethics Approval:
Ethics Approval has been obtained by application to the Research Ethics Committee of the Glasgow Royal Infirmary.
Statistical Analysis
For both CO2 and O2 parameters the mean area under the curve (AUC) will be compared between the diamorphine and fentanyl groups using a normal linear model. This will enable the analysis to adjust for any demographic and clinical variables, which are known to influence either of these indicators of respiratory depression.
There is no previous information in the literature on the variability in area under the curve for either CO2 concentration or O2 saturation. Any specification of effect size must therefore be in terms of a number of standard deviations, where the standard deviation is not known.
We assume that the primary endpoint is the measurement of CO2 over a period of 24 hours and that this will be quantified in the analysis using area under the curve (AUC). If we compare the mean AUC between the diamorphine and fentanyl groups using a two sample t-test (with two-sided significance level 5%) then a study including 40 patients per group would have 80% power to detect a mean AUC difference between groups of 0.634 standard deviations and 90% power to detect a mean AUC difference of and 0.851 standard deviations.
Final Statistical Analysis will be carried out in cooperation with Dr Chris Weir from the Robertson Centre for Biostatistics at the University of Glasgow.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Glasgow, Reino Unido, G4 0SF
- Princess Royal Maternity Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 1st patient on list
- ASA I or II
- BMI <40 at booking
- Term pregnancy +/- 2 weeks gestation
Exclusion Criteria:
- ASA>II
- BMI>40 at booking
- History of Obstructive Sleep Apnoea (OSA)
- Need for supplementation with intravenous Opioids intraoperatively
- Conversion to GA
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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D, F
Group D will be patients at Princess Royal Maternity Hospital in Glasgow, where supplementation with intrathecal diamorphine 300mcg is the current anaesthetic technique of choice. Group F will be patients at the Queen Mother's Maternity Hospital in Glasgow, where supplementation with intrathecal fentanyl 15mcg plus post-operative morphine PCA is the current anaesthetic technique of choice for elective caesarean section. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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transcutaneous carbon dioxide tension
Periodo de tiempo: within the first 24 hours after surgery
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within the first 24 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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oxygen-saturation, respiratory rate, neurological status, need for administration of naloxone and/or active airway management
Periodo de tiempo: within first 24 hours after surgery
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within first 24 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephan Dalchow, FRCA, National Health Service
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 07/S0704/67
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