Prospective observational study to assess the incidence of nausea and vomiting following intrathecal morphine given as apart of anaesthesia for patients with carcinoma cervix undergoing high dose rate (HDR) intracavitary brachytherapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- among patients coming for HDR Brachytherapy for carcinoma cervix
研究概览
简要总结
Women diagnosed with stages I, II and III cervical cancer are treated with chemo-radiation (pelvic external-beam radiation, weekly cisplatin chemotherapy and HDR cervical brachytherapy).
Patients are given anaesthesia during the inpatient brachytherapy procedure that lasts 1 day. In our institution, morphine is used as the intrathecal anaesthetic for pain relief in these patients.
Patients who give informed consent will be recruited for this study.
As per routine practice, spinal anaesthesia with intrathecal morphine will be given as analgesic for brachytherapy.
Patients will be monitored for hemodynamic variables like Heart rate, Blood pressure, Oxygen saturation( SpO2 ) throughout the procedure and also in the recovery room.
Patients will be assessed for i)Nausea and vomiting, ii)need for anti emetics, iii) pain score, iv)need for rescue analgesia,v)sedation score, vi)pruritus and respiratory depression in the recovery room as well as in the
postoperative ward.
Nausea and vomiting will be assessed by nausea vomiting score (0 = No nausea , 1 = Nausea, 2 = Retching, 3=Vomiting)
Pain will be assessed by visual analogue scale ( VAS : 0 to 10 scale in which 0 = no pain, 10 = maximum pain).
Sedation will be assessed by Ramsay sedation score (RSS: 1=Anxious, agitated, restless, 2= Co operative, oriented, tranquil, 3=Responds to command only, 4 = Asleep, brisk response to stimulus,5 = Asleep, sluggish response to stimulus, 6 = Un arousable).
A respiratory rate of < 8 breaths/minute and oxygen saturation of <92% will be taken as respiratory depression
The total dose of opioids administered, the first time of rescue analgesic administered, antiemetics given will be noted and analysed.
The study hypothesis is that intrathecal morphine is a good analgesic with no side effects in patients undergoing Brachytherapy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Histologically proven carcinoma cervix for intracavitary brachytherapy.
- •ASA I/II 3) Consent for participation in study.
排除标准
- •Patient undergoing treatment for chronic pain 2) Preoperative history of nausea and vomiting requiring treatment 3) Unfit for spinal anaesthesia like Coagulopathy, cardiac lesions, infection at the site of spinal injection, fever 4) Unwilling or unable to give consent.
结局指标
主要结局
among patients coming for HDR Brachytherapy for carcinoma cervix
时间窗: With in 24 hours
Incidence of nausea and vomiting following intrathecal morphine
时间窗: With in 24 hours
次要结局
- i) Duration of analgesia with intrathecal morphine which will be measured by(the time to first rescue analgesic)