Effect of Intrathecal Dexamethasone Versus Fentanyl on Post Spinal Shivering in Patients Undergoing Transurethral Prostatectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 51
- 主要终点
- incidence of shivering
研究概览
简要总结
Spinal anesthesia is the technique of choice in transurethral prostatectomy.However,one of the common complications of spinal anesthesia is shivering which is even exaggerated in patients undergoing transurethral prostatectomy.this high incidence is most probably caused by sympathetic block and use of large amount of irrigation fluid during surgery.There are two methods to reduce shivering.Previous studies showed that intrathecal fentanyl is an appropriate method to reduce shivering.Intrathecal dexamethasone could reduce shivering by regulating immune responses.
详细描述
Shivering is an involuntary repetitive contractions of skeletal muscles that increases the basal metabolism and is considered to be a defense mechanism for regulating body temperature in adults .
Post spinal shivering may cause discomfort to the patient,and may aggravate wound pain by stretching incisions and increases intracranial and intra ocular pressure.Shivering may increase tissue oxygen demand as much as 500% and is accompanied by increase in minute ventilation and cardiac output to maintain aerobic metabolism.
Tympanic temperature will be recorded preoperatively,after establishment of spinal anesthesia,and every 15 minutes til the end of operation.Core temperature below 36.5 C is considered as hypothermia Shivering intensity will be assessed with a five -point scale validated by Crossly and Maharaj.
Adverse events like hypotension,bradycardia, respiratory depression,nausea and vomiting will be recorded and treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA(American society of anesthesiologists) physical status grade I-II
- •BMI(body mass index) less than 35 kg/m2
- •patients undergoing transurethral prostatectomy
排除标准
- •patient refusal.
- •patients with contraindications to spinal anesthesia e.g coagulopathy,anti coagulant therapy,allergy to local anesthetic,psychological disorders,...
- •patient with advanced cardiopulmonary diseases or thyroid diseases.
- •patients on corticosteroids therapy or on Alpha2 blocker orAlcohol.
- •patients with initial body temperature above 37.5 C or below 36.5 C.
结局指标
主要结局
incidence of shivering
时间窗: intraoperative every 15 min till the end of surgery and in the recovery room for 2 hours
compare between the effect of intrathecal dexamethasone and intrathecal fentanyl on the incidence of shivering in patients undergoing transurethral prostatectomy
次要结局
- comparative assessment between both drugs(intraoperative and in the recovery room for 2 hours)
研究者
Fatma Mahmoud Ahmed
principal investigator
Zagazig University