A randomised controlled trial comparing an individualised, height–related dose of intrathecal 0.5% hyperbaric bupivacaine with the standard fixed dose of 2.6 ml, for elective Caesarean section

County Durham and Darlington NHS Foundation Trust0 个研究点目标入组 200 人开始时间: 2023年2月22日最近更新: 2023年3月13日

适应症

试验速览

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•1. Height of = 150cm and = 160cm or = 165cm and = 175cm (rounded to nearest cm)
•2. Elective Caesarean section
•3. Singleton pregnancy
•4. Gestation 36 weeks or greater
•5. American Society of Anesthesiologists (ASA) physical status II (appendix 6) with the exception for term BMI = 40
•6. No known foetal abnormalities

•1. Height < 150 cm (rounded to nearest cm)
•2. Height > 175 cm (rounded to nearest cm)
•3. Height = 161 cm and = 164 cm (rounded to nearest cm).
•4. Age < 18 years
•5. Known or anticipated difficult airway
•6. Term BMI > 50
•7. Anterior or posterior placenta praevia
•8. ASA physical status III or greater (appendix 6) with the exception for term BMI = 40
•9. Patients with pre -existing (essential) hypertension or pregnancy –induced hypertension
•10. Contraindication or refusal for spinal anaesthesia
•11. Any neurological disease
•12. Any spinal cord abnormality
•13. Any vertebral column abnormality, such as scoliosis
•14. Congenital or acquired short limbs or any other lower limb abnormality causing a reduction in height
•15. Patients receiving any medications affecting the cardiovascular system
•16. Any additional surgery planned (with the exception of bilateral tubal ligation)
•17. Pre-existing major abdominal pathology (fibroids, significant ovarian cyst)
•18. Known allergy to bupivacaine, fentanyl or morphine
•19. Patients under the care of His Majesty’s Prison
•20. Patients who lack capacity
•21. Patients who require an interpreter for communication

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