Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements: A Randomised Double-Blinded Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- End Tidal Desflurane at Bispectral Index (BIS) 40-60
研究概览
简要总结
Lignocaine is a local anaesthetic that is widely used in all medical and surgical fields. Many clinical studies have shown that intravenous (IV) lignocaine given in the perioperative period was safe, reduced airway complications, obtunds cough reflex, reduce sore throat, pain, opioid consumption, nausea, length of hospital stay. Multiple animal studies have shown that IV lignocaine was able to lower anaesthetic gas requirements. Desflurane is an anaesthetic gas that has a rapid onset and offset of action. This study aims to evaluate the effect of IV lignocaine infusion on desflurane requirements.
Hypothesis of the study is that IV lignocaine infusion reduces desflurane requirements.
详细描述
All volunteers will be randomly assigned into two groups based on computer generated randomisation tables.
Group Lignocaine will receive an IV bolus dose of 1.5 mg/kg of 2% lignocaine HCL diluted up to 10 ml with normal saline in a 10 ml syringe which will be delivered via a syringe pump over a period of 3 min. This is then followed by an IV infusion at the rate of 1 mg/kg/h of 2% lignocaine HCL in a 20 ml syringe which will be administered by another syringe pump.
Group Placebo will receive an IV bolus of 10 ml of normal saline over a period of 3 min followed by an IV infusion of an equal volume of normal saline, both of which will be delivered by separate syringe pumps.
After induction of anaesthesia, all volunteers will be ventilated with Aisys™ CS² anaesthesia machine. Anaesthesia shall be maintained with desflurane, in 50% oxygen-air balance with a total flow of 1.0 L/min. The end tidal desflurane (Et-Des) concentration will be adjusted to maintain a target BIS of between 40-60.
Desflurane and study infusions will be discontinued and estimation of desflurane cost and volume used will be estimated at the end of surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiology (ASA) I or II patients.
- •Patients aged between 18-75 years of age.
- •Patients scheduled for elective laparoscopic cholecystectomy.
- •Patients scheduled for laparoscopic hernioplasty.
- •Patients scheduled for emergency laparoscopic appendicectomy.
- •Patients scheduled for emergency laparoscopic cystectomy.
- •Patient weight ranging from 50 - 100 kg.
- •Surgery lasting at least one hour.
排除标准
- •Patients with a known allergy to study drug.
- •Patients with body mass index (BMI) more than 35 kg m-
- •Patients who are taking sedatives.
- •Patients with chronic substance abuse.
研究组 & 干预措施
Group Lignocaine
Group Lignocaine will receive an IV bolus dose of 1.5 mg/kg of 2% lignocaine HCL diluted up to 10 ml with normal saline in a 10 ml syringe which will be delivered via a syringe pump over a period of 3 min. This is then followed by an IV infusion at the rate of 1 mg/kg/h of 2% lignocaine HCL in a 20 ml syringe which will be administered by another syringe pump.
干预措施: Lignocaine (Drug)
Group Placebo
Patients in Placebo Group will receive an IV bolus of 10 ml of normal saline over a period of 3 min followed by an IV infusion of an equal volume of normal saline, both of which will be delivered by separate syringe pumps.
干预措施: Placebo (Drug)
结局指标
主要结局
End Tidal Desflurane at Bispectral Index (BIS) 40-60
时间窗: Intraoperatively until surgery ends
Percentage of reduction in end tidal desflurane between Lignocaine Group Versus Placebo Group
Volume of Desflurane used to maintain BIS 40-60
时间窗: Intraoperatively until surgery ends
Percentage of reduction of desflurane volume required during surgery between Lignocaine Group Versus Placebo Group
Cost of Desflurane used to maintain BIS 40-60
时间窗: Intraoperatively until surgery ends
Percentage of reduction of cost of desflurane between the 2 groups
次要结局
- Heart rate (beats per minute) intraoperatively(Intraoperatively until surgery ends)
- Systolic, diastolic and mean arterial pressure (mmHg) intraoperatively(Intraoperatively until surgery ends)
- Opioid usage (mcg/kg)(Intraoperatively until surgery ends)