Efficacy of KeLiDex Regimen Compared to Opioid -based General Anaesthesia in Laparotomy Surgeries: A Randomised, Single-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To compare intraoperative hemodynamic variations (as a surrogate of adequate analgesia under controlled anaesthetic depth ) between the groups.
研究概览
简要总结
Participants in the study will undergo General anaesthesia and with Epidural catheter in situ for rescue analgesia. The intervention group will receive loading dose of Ketamine 0.5mg/kg and Lignocaine 1mg/kg in 10 ml syringes which is followed by ketamine 0.1 mg/kg/hr +dexmedetomidine 0.2mcg/kg/hr and Lignocaine 0.25 mg/kg/hr will be given as infusion during maintenance. The comparator group will receive fentanyl 2 mcg/kg in 10 ml volume as bolus followed by 0.5mcg/kg/hr infusion. Other general anaesthesia drugs like propofol used as per titrated to effect and vecuronium (loading dose 0.1 mg/kg, maintenance dose guided by Neuromuscular transmission monitoring. Epidural bolus given with 10 ml 0.2% ropivacaine in 2*5ml aliquots, 5minutes apart if Numeric Rating scale greater than 4 out of 10. Both groups receive low flow anaesthesia with Sevoflurane 3% OR isoflurane 1.5% for induction using Air+ oxygen titrated to MACage 1.1+/-0.1. All patients also receive paracetamol 15 ml/kg, maximum of 1 gm. This study is being done to find efficacy of non-opioid general anaesthesia in intervention versus opioid general anaesthesia in comparator group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Body mass index: 18.5-29.99 kg/m
- •Elective Laparotomy surgeries.
- •American Society of Anesthesiologists physical status (ASA-PS) I and II.
排除标准
- •Patient refusal.
- •Patients with a diagnosis of shock and sepsis.
- •Patients with severe organ failure requiring support like Respiratory, Liver, Cardiac, Renal.
- •Patients with uncontrolled hypertension greater than 150/90 mmHg. Patients with suspected or known autonomic neuropathy.
- •A special group of participants.
- •Preoperative bradycardia or Atrioventricular block Intraoperative circumstances like vasopressor or vasodilation infusion, if required or requiring hypotensive anesthesia, and airway management requiring unconventional techniques and modification of induction and oxygenation.
- •Laryngoscopy and endotracheal intubation time greater than 30 seconds.
结局指标
主要结局
To compare intraoperative hemodynamic variations (as a surrogate of adequate analgesia under controlled anaesthetic depth ) between the groups.
时间窗: 5 minutes before laryngoscopy, immediately after intubation, 5 minutes and 10 minutes after intubation, at the time of incision and 15 minutes thereafter. Vitals will be again noted just before and at 5 minutes post injection of reversal.
Parameters- Heart rate, blood pressure, respiratory rate, oxygen saturation
时间窗: 5 minutes before laryngoscopy, immediately after intubation, 5 minutes and 10 minutes after intubation, at the time of incision and 15 minutes thereafter. Vitals will be again noted just before and at 5 minutes post injection of reversal.
次要结局
- To compare the incidence of tearing during laryngoscopy and intubation.(At the time of laryngoscopy and endotracheal tube intubation.)
- To compare the post extubation seadtion and discharge readiness from Post Anaesthetic care unit.(Parameters- time to reach Modified Aldrete Score, Richmond Agitation Sedation Scale, Likert scale for Post operative Nausea and Vomiting.)
- To compare postoperative 24-hour pain and rescue analgesics consumption.(Numeric Rating Scale at rest and on movement at 10 minutes, 30 minutes, 60 minutes, 120 minutes, 6 hours, 12 hours and 24 hours in the postoperative period.)
研究者
Kausiki Poddar
All India Institute of Medical Sciences, Deoghar