The effect of dexmedetomidine vs placebo on haemodynamic response to skull pin insertion in patients undergoing craniotomy:a randomised blinded comparative study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- To determine the effect of iv inj dexmedetomidine in attenuating the haemodynamic response(SBP,DBP,MAP,HR) to skull pin holder application during craniotomy
研究概览
简要总结
The Mayfield skull pin head holder is used to stabilise the head during neurosurgical procedures.When applied properly,the pins cause considerable periosteal stimulation which results in abrupt increase in Mean Arterial Pressure and cerebral blood flow under general anaesthesia.The haemodynamic responses may lead to brain oedema,increase in ICP or ICH.(1)
The stress response to a nociceptive stimulus is characterised by increased secretion of pituitary hormones and activation of sympathetic system.(1,2)
A number of anaesthetic techniques have been used to obtund the deleterious effects,among which dexmedetomidine is found to be superior.(3,4).Dexmedetomidine is a highly specific,potent and selective alpha 2 agonist.It has analgesic,sedative and anaesthesia sparing effects and it decreases the MAP,HR and sympathetic nervous system in dose dependent fashion.(1).
Altough dexmedetomodine is widely used in our setup,but its use in obtunding the above mentioned deleterious effects is not studied in our population yet.In this randomised controlled study,the null hypothesis that dexmedetomidine doesn’t reduce MAP and HR will be investigated.We will primarily try to compare the effect between iv inj dexmedetomidine given iv at the dose of 1microgram per kg bodyweight over 10 mins before induction of anaesthesia and placebo(inj sodium chloride0.9%) given iv over 10 mins before the induction of anaesthesia on attenuating the SBP,DBP,MAP and HR at the time of pin insertion,1,5,10,15mins after pin insertion .Secondarily we will try to see (a) the effect of inj dexmedetomodine in attenuating haemodynamic response(SBP,DBP,MAP and HR) during laryngoscopy and intubation (b) compare the plasma glucose level before and after pin insertion
REFERENCES:
(1)Renganathan T,Venkatesan G.Comparative study to evaluate the effect of dexmedetomidine in attenuating the haemodynamic and neuroendocrine responses to skull pin holder application during craniotomy.J.Evid.Based Med.Heathc.2017;4(31):1814-1819.
(2)Desborough JP.The stress response to trauma and surgery.Br J Anaesthesia.2000 Jul;85:109-117
(3)Paul A,Krishna HM.Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy.Indian J Anaesthesia.2015;59(12):785-788
(4)Thongrong C,Sirikannarat P,Kasemsiri P,Duangthongphon P.Comparison of dexmedetomidine and fentanyl to prevent haemodynamic response to skull pin application in neurosurgery:double blind randomized controlled trial.Anaesthesiology Intensive Therapy.2017;49(4):268-73
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA I and II 2.Elective surgery 3.Pre operative GCS 15 4.Patients giving valid consent.
排除标准
- •1.Pre operative heart rate less than 45 2.Pregnancy 3.Known allergy to dexmedetomidine 4.Second or third degree haeart block.
结局指标
主要结局
To determine the effect of iv inj dexmedetomidine in attenuating the haemodynamic response(SBP,DBP,MAP,HR) to skull pin holder application during craniotomy
时间窗: At the time of pin insertion,1,5,10,15 mins after pin insertion
次要结局
- To determine the effect of iv inj dexmedetomidine in attenuating the haemodynamic response(SBP,DBP,MAP,HR) during laryngoscopy and intubation
- To compare the plasma glucose level before and after pin insertion(15 mins before the administration of inj dexmedetomidine or placebo(baseline) and 30 and 60 mins after pin insertion)