Intra-operative hypotension with three different epidural regimens in patients undergoing laparotomy for Carcinoma Ovary- a pilot study for a randomised controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 1. Number of episodes of intraoperative hypotension (defined as mean arterial blood pressure less than 70 mmHg) from the time of laparotomy incision to two hours from laparotomy incision.
研究概览
简要总结
This study is a randomised controlled, double blinded, parallel group, single centre study to compare three different intra-operative epidural regimens and investigate their propensity to cause intra-operative hypotension as defined by a mean arterial blood pressure less than 70 mmHg. The three epidural regimens are only bupivacaine, only morphine or both. The primary outcome is the number of episodes of intraoperative hypotension and the mean of the mean arterial blood pressure of these episodes. The secondary outcomes are the ephedrine and/or phenylephrine requirement, maximum noradrenaline requirement and duration of noradrenaline requirement and fluid requirements. All measurements will be done from the time of administration of the study drug which is at laparotomy incision to two hours from then. The hypothesis is that the combination of epidural bupivacaine and morphine is likely to cause more hypotension than the comparators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age greater than 18 years 2)Carcinoma Ovary patients posted for elective open staging laparotomy 3)ASA (American Society of Anaesthesiologists) physical status 1,2 and 3 patients.
排除标准
- •1.Patients not consenting/contraindication to epidural.
- •2.ASA4 and above patients.
- •3.Low preoperative BP (systolic BP less than 100mmHg) either during pre-medication visit or the baseline vitals on shifting to operating theatre.
- •4.Patients with low ejection fraction (less than 50%) and/or regional wall motion abnormalities.
- •5.Patients declared inoperable after diagnostic laparoscopy.
- •6.Patients with allergy to any of the study drugs 7.Patients with severe or massive ascitis or in obstruction.
- •8.Patients with a low preoperative BMI less than 18.5 kg/m
- •9.Patients with marked hypoalbuminemia (Serum albumin less than 2.5 g/dL)
- •Any emergency surgeries.
结局指标
主要结局
1. Number of episodes of intraoperative hypotension (defined as mean arterial blood pressure less than 70 mmHg) from the time of laparotomy incision to two hours from laparotomy incision.
时间窗: Starting point of measurement: Time of laparotomy incision | End point of measurement: two hours from the point of laparotomy incision
2. Mean of the mean arterial blood pressure (in mmHg) during these intra-operative hypotension episodes from laparotomy incision to two hours from laparotomy incision.
时间窗: Starting point of measurement: Time of laparotomy incision | End point of measurement: two hours from the point of laparotomy incision
次要结局
- Total dose of ephedrine in milligrams and/or phenylephrine in micrograms to treat this Intraoperative hypotension(From laparotomy incision to two hours from laparotomy incision.)
- Maximum dose of noradrenaline requirement in mcg/kg/min to treat Intraoperative hypotension and duration of Noradrenaline requirement.(From laparotomy incision to two hours from laparotomy incision.)
研究者
Dr Nairita Das
Cancer Institute (WIA) Adyar, Chennai