Comparison of perioperative hypothermia with intrathecal morphine (ITM) vs intrathecal fentanyl (ITF)in parturients planned for caesarean section under spinal anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- incidence of hypothermia in the two groups
研究概览
简要总结
Neuraxial anaesthesia is a proven, rapid and common anaesthetic technique for caesarean delivery (CD). It is safe, inexpensive, easy to perform with low failure rates, and has low LAST rates. The technique has benefits of an awake mother at delivery with high maternal satisfaction rates and prevents aspiration pneumonia. intrathecal opioids are used as an adjuvant to improv ethe quality of analgesia and anaesthesia for the procedure. Intrathecal opioids may also contribute to the hypothermia due to the cephalad movement of the drug.Engorgement of the epidural veins and increased lumbar lordosis during pregnancy may have enhanced the cephalad migration of the opioids placed in the CSF. fentanyl and morphine are two such opioids commonly used as an adjuvant to spinal anaesthesia. The effect of both these drugs on the temperature of the patient has discussed as anecdotal reports in literature. Therefore, the present study has been designed to study the effect of intrathecal morphine as compared to intrathecal fentanyl on the core temperature with its associated symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Parturients planned for elective caesarean section under spinal anaesthesia.
排除标准
- •1.ASA Status ≥ 3 2.Refusal to take part in study.
- •3.Core temperature less than 36.0 â°C degrees in the preoperative assessment.
- •4.Contraindications for spinal anaesthesia (any bleeding disorder or coagulation abnormality).
- •5.Patients with any allergy to study medication (Morphine, Fentanyl, Bupivacaine).
- •6.Patient taking medications which impact thermoregulation (vasodilators, Antipsychotics).
- •7.Twin pregnancy.
- •8.Conversion of spinal anaesthesia to GA.
结局指标
主要结局
incidence of hypothermia in the two groups
时间窗: 0,15,30,45,60,75,90,105,120 minutes of spinal anesthesia | 0,30,60,90,120 min post surgery | 3,4,5,6,7,8,9,10,11,12 hours post surgery
次要结局
- 1. Incidence of shivering(2. Duration of maximum temperature fall following intrathecal morphine and intrathecal fentanyl)
研究者
Garinepally Surya Deep
Post Graduate Institute of Medical Education and Research