A randomized prospective comparative clinical study of Hemodynamic responses during bladder hydrodistension under general versus spinal anaesthesia in patients with interstitial cystitis in department of anaesthesia, SMS Medical College, Jaipur
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine and compare the maximum increase in heart rate, mean arterial pressure, systolic blood pressure and diastolic blood pressure during bladder hydrodistension from baseline in general versus spinal anaesthesia.
研究概览
简要总结
Interstitial cystitis , a disease of lower urinary presents with symptoms of chronic bladder pain and increased urinary frequency which results in impaired quality of life of patients. The diagnosis of interstitial cystitis is difficult to make as well as the disease is difficult to treat. Bladder hydrodistension is not only a diagnostic tool but also a treatment option for the patients of interstitial cystitis. patients who are undergoing bladder hydrodistension show a marked autonomic response during the procedure resulting in increase in heart rate and blood pressure . Thus blocking the abrupt increase in blood pressure and heart rate associated with autonomic response during bladder hydrodistension in patients with interstitial cystitis is essential for patients safety.
Hence, we have designed this study to compare hemodynamic responses during bladder hydrodistension in patients with interstitial cystitis under general versus spinal anaesthesia. So that appropriate anaesthetic procedure can be used for patient’s safety during surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled for elective bladder hydrodistension.
- •Patients willing to give informed consent.
- •American Society of Anaesthesiologist physical status I-III.
排除标准
- •1.Patient should not be part of any other study.2.Un-cooperative patient.3.Patient who is allergic to any drug of general or spinal anaesthesia.4.Patient who is on anticoagulants.5.Patients with raised intra cranial pressure.6.Patients with severe cardiovascular diseases.7.Patients with spinal deformity or local site infection.
结局指标
主要结局
To determine and compare the maximum increase in heart rate, mean arterial pressure, systolic blood pressure and diastolic blood pressure during bladder hydrodistension from baseline in general versus spinal anaesthesia.
时间窗: To determine and compare the maximum increase in heart rate, mean arterial pressure, systolic blood pressure and diastolic blood pressure at baseline, 2 minutes after induction, 5 minutes, 15 minutes, 25 minutes, 35 minutes and 45 minutes during bladder hydrodistension from baseline in general versus spinal anaesthesia.
次要结局
- 1.To evaluate post-operative pain using NRS pain score during their stay in post anaesthesia care unit (PACU).(30 minutes after completion of procedure.)
研究者
Dr Anupama Gupta
Sawai Man Singh Medical College