Comparison of intravenous dexamethasone with intravenous paracetamol, to prevent post spinal shivering, in patients undergoing Trans-urethral resection of Prostate – A Randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- SELF
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- 1.Incidence of shivering
研究概览
简要总结
The study proposal aims to compare the efficacy of intravenous dexamethasone with intravenous paracetamol in preventing post-spinal shivering in patients undergoing transurethral resection of the prostate (TURP).
There is a high prevalence of hypothermia and shivering in TURP surgeries, particularly in older patients with comorbidities.
The rationale underscores the lack of a definitive treatment for post-spinal shivering and proposes dexamethasone and paracetamol as potential interventions due to their mechanisms of action. The novelty lies in comparing these drugs specifically in the context of TURP surgeries. The expected outcome is a decreased incidence of post-spinal shivering and its adverse effects. The research question revolves around whether paracetamol is more effective than dexamethasone in preventing post-spinal shivering or vice versa.
The primary objective is to evaluate the Incidence, Time of onset, severity of post-spinal shivering, in TURP after the administration of paracetamol or dexamethasone and requirement of IV Pethidine for treatment of grade 3 or 4 shivering (according to Crossley and Mahajan shivering grades) .
Secondary objectives include studying the side effects of the drugs - Nausea, vomiting and Hypotension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.All patients posted for Trans Urethral Resection of Prostate procedure.
- •2.The patients who belong to American Society of Anesthesia 1, 2 and 3 physical statuses.
排除标准
- •1.Patients with spinal deformity.
- •2.Patients with allergic history to the drugs used in this study.
- •3.Any contraindication to subarachnoid block.
结局指标
主要结局
1.Incidence of shivering
时间窗: TIME POINT A: Pre operative value during pre anaesthetic evaluation | TIME POINT B : Prior to spinal anaesthesia | TIME POINT C : Intra operatively for every 5 minutes upto 30 minutes from onset of spinal anaesthesia | TIMEPOINT D : For every 30 minutes upto 180 minutes frm he onset of spinal anaesthesia in he post operative period
2.Severity of shivering
时间窗: TIME POINT A: Pre operative value during pre anaesthetic evaluation | TIME POINT B : Prior to spinal anaesthesia | TIME POINT C : Intra operatively for every 5 minutes upto 30 minutes from onset of spinal anaesthesia | TIMEPOINT D : For every 30 minutes upto 180 minutes frm he onset of spinal anaesthesia in he post operative period
3.Time to first onset of shivering
时间窗: TIME POINT A: Pre operative value during pre anaesthetic evaluation | TIME POINT B : Prior to spinal anaesthesia | TIME POINT C : Intra operatively for every 5 minutes upto 30 minutes from onset of spinal anaesthesia | TIMEPOINT D : For every 30 minutes upto 180 minutes frm he onset of spinal anaesthesia in he post operative period
4.Total consumption of anti-shivering medication (IV Pethidine)
时间窗: TIME POINT A: Pre operative value during pre anaesthetic evaluation | TIME POINT B : Prior to spinal anaesthesia | TIME POINT C : Intra operatively for every 5 minutes upto 30 minutes from onset of spinal anaesthesia | TIMEPOINT D : For every 30 minutes upto 180 minutes frm he onset of spinal anaesthesia in he post operative period
次要结局
- • side effects such as nausea, vomiting (treated using Metoclopramide 10 mg IV) will be recorded & considered as secondary outcome & treated accordingly.(• Any serious adverse events such as anaphylactic or cardiac arrest during monitoring would be managed immediately & reported to the ethics committee.)
研究者
Rahul G Bhat
SDM College of Medical Sciences and Hospital