Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries
试验速览
- 阶段
- 4 期
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Blood pressure from base line will be measured and hypotension will be described and treated as in description section
研究概览
简要总结
A study to compare between intravenous atropine and glycopyrrolate in preventing spinal anesthesia induced hypotension in patients undergoing major lower limb orthopedic surgeries. Hypotension is the most common complication in spinal anesthesia that can be life threatening. If this can be prevented patients comfort can be increased and satisfaction as well.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA PS I and II,
- •age 16 to 65,
- •undergoing lower limb major orthopedic surgery,
- •willing to participate
排除标准
- •Contra indication to spinal anesthesia,
- •patient refusal,
- •ASA PS >III,
- •cardiac diseases,
- •hypertension >160/ 100,
- •arrhythmias,
- •Acute coronary syndrome,
- •patients taking beta-blockers,
- •hepatic and pulmonary diseases
研究组 & 干预措施
Atropine sulphate
Atropine 5 mcg/kg diluted in normal saline to total volume of 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blood pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly
干预措施: Atropine (Drug)
Glycopyrrolate
Glycopyrrolate 2.5 mcg / kg diluted in normal saline to total volume of 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blold pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly.
干预措施: Glycopyrrolate (Drug)
Normal Saline
Normal saline 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blold pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly.
干预措施: Normal Saline Flush, 0.9% Injectable Solution (Drug)
结局指标
主要结局
Blood pressure from base line will be measured and hypotension will be described and treated as in description section
时间窗: From anesthesia to 2 hrs after completion of surgery
Systolic arterial pressure \<90 mm of hg or 20% decrease from base line or decrease in blood pressure 30 mm Hg or more from base line will be considered hypotension. Hypotension along with tachycardia (as described below) will be treated with phenylephrine 100 mcg and hypotension alone will be treated with mephentermine 6 mg bolus
Heart rate will be monitored and treated accordingly
时间窗: Iv atropine or glycopyrrolate to 2 hrs after completion of surgery
Heart rate \> 100 Bpm or more or more than 20% from base line will be described as tachycardia. Heart rate less than 50 bpm or less than 20% from baseline will be described as bradycardia
次要结局
- Incidence of Nausea and vomiting will be described and treated accordingly.(Initiation of spinal anesthesia to 2 hrs after surgery)
研究者
Raju Thapamagar
Principal investigator
B.P. Koirala Institute of Health Sciences