Opioid Free Anesthesia Versus Opioid Based Anesthesia for Improvement of the Surgical Field Condition in Elderly Patients Undergoing Arthroscopic Shoulder Surgery. A Randomized Comparative Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- change in MBP
研究概览
简要总结
Arthroscopic shoulder surgeries are commonly used as a minimally invasive surgery for shoulder diseases. however, it causes moderate-to-severe pain and needs stabilization of hemodynamics, without compromising the patient, to the degree that lessens the intraarticular bleeding to provide adequate visualization by the surgeon owing to inability to use a tourniquet in this situation.
Opioids have known side effects, like respiratory depression, postoperative nausea and vomiting, pruritus, difficulty in voiding, and ileus. These complications may lead to a prolonged hospital stay.
The elderly patients are predisposed to a greater hemodynamic changes due to the higher resting sympathetic tone ,altered beta receptor sensitivity , depleted intravascular volume because of frequent use of diuretics, increased myocardial stiffness ,increased arterial stiffness, reduced sinus node function and baroreceptor responsiveness and other patients comorbidities. So they are at increased risk complications as myocardial infarction, stroke and delirium.
Opioid free anesthesia is a technique with no opioids administered intraoperatively through either systemic, neuraxial, or tissue infiltration routes. The number of case reports and small prospective studies from all over the world supports its benefits.
OFA depends on combinations of non-opioid agents and adjuncts, including lidocaine, magnesium, dexmedetomidine, ketamine,and dexamethasone to produce anesthesia, and analgesia.
Dexmedetomidine is an a2 agonist that possesses anxiolytic, anesthetic, hypnotic, and analgesic properties. In addition, it reduces the pressor responses mediated by the sympathetic nervous system.
Lignocaine is a short-acting amide local anaesthetic agent. It is potent as a sodium channel blocker and has been shown to provide excellent analgesia when administered intravenously . The evidence base supports lignocaine as an analgesic agent, an opioid-sparing agent, an anti-inflammatory and a co-anaesthetic.
n,Complex regional pain syndrome,opioid-tolerant patient and early recovery after surgery, however, few studies focused on its ablility to improve the surgical field condition which depends on the hemodynamics especially in elderly patients.
Aim is to Compare OFA with Opioid anesthesia (OA) as regards improvement of the surgical field condition in elderly patients undergoing arthroscopic shoulder surgery under general anesthesia.
详细描述
Arthroscopic shoulder surgeries are commonly used as a minimally invasive surgery for shoulder diseases. however, it causes moderate-to-severe pain and needs stabilization of hemodynamics, without compromising the patient, to the degree that lessens the intraarticular bleeding to provide adequate visualization by the surgeon owing to inability to use a tourniquet in this situation.
Controlling the pain in shoulder surgery facilitates early mobilization, fast functional recovery and allows pain-free muscle contraction.
Opioids have known side effects, like respiratory depression, postoperative nausea and vomiting, pruritus, difficulty in voiding, and ileus. These complications may lead to a prolonged hospital stay.
The elderly patients are predisposed to a greater hemodynamic changes due to the higher resting sympathetic tone ,altered beta receptor sensitivity , depleted intravascular volume because of frequent use of diuretics, increased myocardial stiffness ,increased arterial stiffness, reduced sinus node function and baroreceptor responsiveness and other patients comorbidities. So they are at increased risk complications as myocardial infarction, stroke and delirium.
Opioid free anesthesia is a technique with no opioids administered intraoperatively through either systemic, neuraxial, or tissue infiltration routes. The number of case reports and small prospective studies from all over the world supports its benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I or II
- •aged > 65 years
- •undergoing arthroscopic shoulder surgery under general anesthesia.
排除标准
- •uncontrolled systemic diseases
- •significant organ dysfunctions
- •morbid obesity (BMI >35)
- •history of allergy to the study drugs
- •use of beta blockers
- •chronic use of opioids
研究组 & 干预措施
opioid free (OFA) group
1000 mg paracetamol + dexmedetomidine 1 µg/kg over 10 min as loading dose and dexamethasone 0.1 mg/kg and lidocaine 1 mg/kg IV bolus Then continuous infusion of dexmedetomidine at a rate of 0.5 µg/kg/h with lidocaine 2 mg/kg/hr and magnesium sulfate 1.5 g/hr during surgery .
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
change in MBP
时间窗: at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.
measuring mean blood pressure
次要结局
- change in SBP(at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.)
- change in HR(at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.)
- Grades of surgical field bleeding, correlation between the difference in MAP and the grade of the surgical field.(1 minute after visualizing the field with the arthroscope and then every 10 min till the end of surgery)
- AMT score(after recovery from anesthesia (PACU AMT), 6 hours after surgery (Day-0) and on the next three postoperative days (Day-1, Day-2 and Day-3) at the same time of evaluation on day 0.)
- Postoperative complications as nausea, vomiting, bradycardia, hypoxia, shivering and delirium(within 2 hours in the PACU)
研究者
Dalia Ismail
Lecturer of Anesthesia, Surgical ICU and pain management at Faculty of medicine Cairo University
Cairo University
