Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- nausea and vomiting score in patient during caesarean delivery
研究概览
简要总结
Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery under Spinal Anesthesia
详细描述
This prospective randomized control study will be held in Sohag University Hospital After approval of local ethics committee of sohag university hospital from June 2022 to December 2022, written informed consent will be taken from all patients , about advantages and possible complications of this study .
Inclusion criteria This study will include 90 Patients , physical status I or II according to ASA classification , age between ( 18 - 45 years ) undergoing cesarean delivery under spinal anesthesia.
Technique :
On arrival of patient to operative room :
- 20G IV line ( cannula ) will be inserted .
- Putting of patient on monitor and assessment of hemodynamics ( HR , RR , BP ) .
- Pre anesthetic hydration by at least 1000 ml ringer lactate
- Patient received Spinal anesthesia at level L3-L4 or L4-L5 lumbar segement .
- during the procedure, If patient suffer from :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •physical status I or II according to ASA classification with age between ( 18 - 45 years ) undergoing cesarean delivery under spinal anesthesia.
排除标准
- •patient refusal .
- •Any contraindication of neuraxial block.
- •Patients with physical status other than 1 and 2 according to ASA classification
- •Those with history of nausea and vomiting as Parturients with a history of motion sickness, hyperemesis gravidarum , also those who received anti emetic drugs in last 2 hours of operation .
- •Allergy to any of the drug included in this study .
- •complicated pregnancy as placenta previa, preeclampsia and eclampsia multible pregnancy
- •fetal distress
研究组 & 干预措施
Fentanyl group
Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 20 μg (0.5 mL) fentanyl IT.
1 mL IV normal saline immediately after the placement of the spinal.
干预措施: Fentanyl (Drug)
Granisetron group
Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 0.5 mL normal saline IT.
1 mg (1 mL) IV granisetron after spinal placement.
干预措施: intravenous graniseton (Drug)
Control group
10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml
1 ml normal saline IV after spinal placement.
干预措施: Bupivacain (Drug)
结局指标
主要结局
nausea and vomiting score in patient during caesarean delivery
时间窗: six month
: To compare intrathecal (IT) fentanyl with IV granisetron for preventing intraoperative nausea and vomiting during cesarean deliveries performed with spinal anesthesia. according to nausea and vomiting scale ( from 0 = no nausea , to 10= resistant nausea and vomiting )
次要结局
未报告次要终点
研究者
Mohamed Youssef Mohamed
Principal Investigator
Sohag University