Comparision of the Effect Between Dexmedetomidine And Fentanyl on Median Effective Concentration (EC 50) of Propofol for I gel insertion: A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- Ankur Luthra
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- EC 50 of propofol: The effective concentration of propofol will be recorded in all groups and will be used to calculate the EC50
研究概览
简要总结
When propofol is used alone for induction, it produces minimal analgesia and large doses are required to induce general anaesthesia. Excessive depth of anaesthesia, and significant cardiovascular and pulmonary depression may result. To overcome these drawbacks, sedative and analgesics have been co-administered with propofol for anaesthesia induction. Dexmedetomidine has analgesic and sedative properties. Premedication of this drug can significantly reduce the requirement of propofol for induction of anaesthesia. Fentanyl reduces the median effective concentration of propofol for various noxious stimuli by 50 %. Fentanyl combined with propofol also has a depressive effect on haemodynamics. Also, a high target concentration of propofol itself (8 mg/ml) decreased MBP and increases frequency of apnea.
The present research is aimed to determine whether low dose Dexmedetomidine (0.5 mics/kg) is sufficient to decrease the propofol requirement for anaesthesia induction. We therefore intend to compare the median effective concentration (EC50 ; the concentration at which loss of consciousness occurred in 50 % of patients) of propofol for induction of anaesthesia comparing dexmedetomidine with fentanyl. We aim to determine the predicted EC50 of propofol for I-gel insertion(airway device) using TCI (Diprifusor) and will compare the propofol requirement for induction with fentanyl and low dose dexmedetomidine in patients undergoing elective ambulatory day care surgeries. We will be recording the BIS, haemodynamics, adverse events during induction and number of attempts of I-gel insertion, emergence time and duration of PACU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American Society of Anesthesiologists physical status I or II 2.Age of 20–60 years 3.Either gender 4.Estimated operation time of ≤ 2 hours and anaesthesia time of ≤ 3 hours 5.Written informed consent to undergo the therapeutic regimen.
排除标准
- •1.Renal dysfunction (serum creatinine > 1.2mg/dl) 2.Liver dysfunction (liver enzymes twice the normal range or higher) 3.History of chronic use of sedatives/ narcotics or analgesics/Beta blockers 4.BMI more than 30 kg/m2 or less than 15 kg/m2 5.Allergy to study medication.
结局指标
主要结局
EC 50 of propofol: The effective concentration of propofol will be recorded in all groups and will be used to calculate the EC50
时间窗: EC 50 of propofol: The effective concentration of propofol will be recorded in all groups just before insertion of I-gel airway and will be used to calculate the EC50
次要结局
- Occurrence of any adverse events and duration of stay(In Post anaesthesia care unit postoperatively)
- Total Propofol requirement for induction in each group
- Emergence time(At the end of surgery to eye opening)
- Time to remove the airway device(At the end of surgery)
- Degree of sedation by RASS scale(Every 10 min from arrival in post anaesthesia care unit till discharge)
- Haemodynamic indices including Systolic Blood Pressure, Diastolic blood pressure and Mean Arterial Pressure, Heart Rate, Oxygen saturation(From preoperative to Discharge every 10 minutes)
- Intraoperative MAC requirement(Every 10 minutes intraoperatiely)