PREEMTIVE ANALGESIA TO ATTENUATE PEERIOERATIVE STRESS RESPONSE OF SURGERY IN GENERAL ANAESTHESIA : RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study effect of pre-emptive analgesia on hypothalamic pituitary adrenal neuroendocrinal stress response axis during perioperative period by measuring levels of blood adrenaline , cortisol and glucose in patient undergoing surgery in general anaesthesia
研究概览
简要总结
AIM To study preemptive analgesia to attenuate surgical stress response in General Anaesthesia during perioperative period
RATIONAL
Surgical stimulus result in neuroendocrinal catabolic and inflammatory immune stress response which is harmful to the patient
General anaesthesia does not block surgical stimulus afferent pathway, therefore stress response persist even after general anaesthesia through hypothalamus pituitary adrenal axis
Local anaesthetic agent in form of nerve block local infiltration or regional anaesthesia block afferent pathway to hypothalamus pituitary adrenal axis and thus surgical stress response
Preemptive analgesia in form of local anaesthetic infiltration Nerve block at surgical site along with general anaesthesia blocks afferent nerve signal to central hypothalamic pituitary adrenal axis completely
We hypothesized that preemptive analgesia is likely to block surgical stress during general anaesthesia by blocking the afferent pathway to hyothalamus pituitary adrenal axis which is measured by levels of adrenaline, cortisol and blood sugar levels
Patient diagnosed with Chronic Suppurative Otitis Media with blood investigation Within normal limit
ASA grade I Male patients undergoing tympanoplasty mastoidiectomy in general anaesthesia Randomised in two group A and B with chitbox method
AGE 18 to 60 years 40 Kg and above
Group A CONTROL General anaesthesia
Group B STUDY General anaesthesia with local infiltration and post auricular nerve block
Sample site VCSG department of anaesthesia
Blinding Double blind Patient and investigator will be blinded
Patient will be given General anaesthesia as routine
Premedication midazolam 0.05mgper kg glycopyrrolate 0.2mg Fentanyl 2 mcg per kg Inj Paracetamol 15mg per Kg less than 50 Kg and 1g more 50kg over 10 minutes
10 percentage lignocaine spray 6 puff 60 mg in oropharyngeal airway with deep inhalation to attenuate endotracheal intubation response.
Induction with propofol 2mg per kg followed by endotracheal intubation
Maintenance with nitrous oxide sevoflurane and vecuronium
EtCO2 35 to 40 mmhg
PREEMTIVE ANALGESIA
DRUG BUPIVACAINE 0.5percentage 3mg per Kg Volume 15 ml Local infiltration Pre post auricular and aural canal areas after General anaesthesia before surgical incision
Postauricular auriculotemporal 5 Nr Branch Vagus and glassophyrngeal
Blood investigation Adrenaline Cortisol blood sugar level
Timing of sample
1. Basal In preoperative area
2. 3 mins after incision
3. 63 mins after incision
4. 123 mins after incision
5. 1 hr after extubation
Heart Rate Blood Pressure Mean arterial pressure Temperature monitoring Basal, 10 mins after intubation and 3 mins after incision and every 10 mins upto 1hr post extubation
To analyze Visual Analogue Scale at end of surgery 10 minutes after Extubation
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 60.00 Day(s)（—）
- 性别
- All
入选标准
- •ASA GRADE1 patients with Chronic otitis media undergoing TYMPANOPLASTY under GENERAL ANAESTHESIA.
- •Weight above 40kg.
排除标准
- •ASA 2, 3,4, Weight below 40kgs patients allergic to bupivacaine.
- •patients on Beta blockers or other antihypertensive drugs.
结局指标
主要结局
To study effect of pre-emptive analgesia on hypothalamic pituitary adrenal neuroendocrinal stress response axis during perioperative period by measuring levels of blood adrenaline , cortisol and glucose in patient undergoing surgery in general anaesthesia
时间窗: Stress response evaluated measuring Serum Adrenaline, Cortisol and Blood Glucose level at Basal Level, 10 mins post intubation, 3 mins post incision , 63 mins post incision, 123 mins post incision and 1hr after extubation.
次要结局
- To corelate perioperatiove stress response with haemodynamic clinical parameters of Blood pressure , Mean arterial pressure heart rate(Visual analogue score at end of surgery after extubation.)
研究者
Dr Satyendra Yadav
VCSGGIMS and RESEARCH associated HNB BASE TEACHING HOSPITAL