The Effect of Esmolol Versus Dexmedetomidine on Postoperative Pain Control in Endoscopic Sinus Surgery: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- opioid (morphine) consumption up to 24 hours after end of the surgery.
研究概览
简要总结
Hypotensive techniques are associated with certain disadvantages. Hence, anesthesiologists are still in search of drugs with fewer side effects.
Various drugs such as high-concentration volatile anesthetics, magnesium sulfate, remifentanil, clonidine, calcium channel blockers, tranexamic acid, intravenous nitroglycerin, and sodium nitroprusside have been evaluated to control blood pressure and decrease blood loss during surgery, thereby improving the surgical field quality.
Opioids are the mainstay of treatment for perioperative pain, but their administration increases the incidence of respiratory complications, slows down normal gastrointestinal motility, and prolongs hospital stay. With the development of enhanced recovery after surgery (ERAS), reducing the use of opioids in the perioperative period has become the common goal of anesthesiologists. The dosage of opioids should be strictly controlled whenever possible, which should not only meet the needs of analgesia perioperatively, but also minimize the incidence of adverse reactions.
Opioid-free anesthesia (OFA) represents a step forward in anesthetic practice as it potentially spares the use of opioids by administrating nonopioid agents and adjuncts. The rationale to propose OFA is based on the aim to avoid the negative impact of intraoperative opioids on a patient's postoperative outcomes.
Several studies showed that β adrenergic receptor antagonists withhold the upsurge of catecholamines circulating in blood which induced by surgery, as well as having analgesic sparing effect itself. Esmolol is an ultrashort acting β1 blocking drug that has been uncovered to own opioid-sparing effects likely due to resemblances in its structure with local anesthetic agents. Esmolol's short course of action and titrability offer it as an attractive drug to use, although the mechanism of action of its analgesic effect has yet to be established.
Dexmedetomidine hydrochloride is a specific alpha-2 adrenoreceptor agonist that has intrinsic analgesic and sedative properties coupled with anxiolytic and sympatholytic effects. It minimizes the hemodynamic and neuroendocrine responses to anesthesia and surgery by suppressing the sympathetic tone. This hemodynamic stability can improve the surgical outcome as well as both patient and surgeon satisfaction. Dexmedetomidine accompanied by other anesthetics causes a controlled reduction in blood pressure and heart rate and improves the quality of the surgical field.
Alpha-2 adrenergic agonists (dexmedetomidine) have pharmacologic characteristics (sedation, hypnosis, anxiolysis, sympatholytic, and analgesia) that make them suitable as adjuvants to multimodal analgesia.
Their anti-nociceptive effect is attributed to the stimulation of a2- adrenoceptors located in the central nervous system. Dexmedetomidine is a highly selective and potent a2-adrenoceptor agonist. Its intrathecal administration leads to anti-nociceptive effects, although it does have some undesired side effects (e.g., hypotension, bradycardia, and sedation).
详细描述
This randomized prospective study will be carried out in Tanta university hospital in the ENT surgery department on 70 Patients with American Society of Anesthesiologists (ASA) Physical Status Class I &II, aged > 18 years and scheduled for FESS.
After approval from the institutional ethics committee, informed consent will be obtained from all participants parents in this research.
A computer system will be used for randomization by creating a list of number each number referred to one of the two groups. Block randomization will be used to ensure equality of the groups. Each number will be sealed in an opaque envelope. Then, each patient will be asked to choose one of the envelopes and give it to an anesthesiologist who compared it to the computer-generated list and hence assigned her to one of the two groups. The anesthesiologist, participant and outcomes Assessor will be blinded to the collected data until the end of the study and administered the medication.
The patients will be taken to the preoperative room 30 minutes before the operation. Patients are randomly divided into two groups ( 35 each):
In group A (dexmedetomidine group): 35 patients will be received dexmedetomidine (Precedex; Abbott Laboratories, North Chicago, Illinois, USA) (vial = 2 ml) 100 mcg/ml at bolus dose of 1 mcg /kg slowly infused over 10 min, then continuous infusion by a rate of 0. 5 mcg /kg/h., infused by a syringe pump. infusion stopped immediately upon extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A computer system will be used for randomization by creating a list of number each number referred to one of the two groups. Block randomization will be used to ensure equality of the groups. Each number will be sealed in an opaque envelope. Then, each patient will be asked to choose one of the envelopes and give it to an anesthesiologist who compared it to the computer-generated list and hence assigned her to one of the two groups. The anesthesiologist, participant and outcomes Assessor will be blinded to the collected data until the end of the study and administered the medication.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 patients with American Society of Anesthesiologists (ASA) Physical Status Class I&II, aged > 18 years. and scheduled for FESS.
排除标准
- •The patients on β-blockers and cardiovascular active drugs
- •History of neuromuscular disorder, diabetic neuropathy, pregnancy
- •Prolonged QT interval and ventricular arrhythmia, specifically a pre-disposition to bradycardia or conduction abnormalities, cyanotic cardiac disease, and use of medications that would increase the risk of bradycardia.
- •Current (Within the last 30 days) opioid use for pain control as sickle cell disease, substance abuse or benzodiazepine addiction
- •History of end stage hepatic, renal, diabetes mellitus, and bleeding disorders,
- •Allergy and hypersensitivity to the drugs used in the study
- •Excessive use of analgesics/non-steroidal anti-inflammatory drugs
- •Morbid obesity (body mass index (BMI) > 40)
- •A positive history of motion sickness, women who had a history of nausea and vomiting before menstruation.
研究组 & 干预措施
dexmedetomidine group
35 patients will be received dexmedetomidine (Precedex; Abbott Laboratories, North Chicago, Illinois, USA) (vial = 2 ml) 100 mcg/ml at bolus dose of 1 mcg /kg slowly infused over 10 min, then continuous infusion by a rate of 0. 5 mcg /kg/h., infused by a syringe pump. infusion stopped immediately upon extubation.
干预措施: Dexmedetomidine (Drug)
Esmolol group
35 patients will be received i.v. received a loading dose of esmolol 0.5 mg/kg in 30 mL isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min. infusion stopped immediately upon extubation.
干预措施: Esmolol Esterase (Drug)
结局指标
主要结局
opioid (morphine) consumption up to 24 hours after end of the surgery.
时间窗: first 24 hs following surgery.
opioid (morphine) consumption up to 24 hours after end of the surgery.
次要结局
- visual analog scale (VAS) score for pain ( maximum score was 10 which mean sever pain and least score was 0 which mean no pain)(in the PACU at 24 hours in surgical ward)
研究者
Amany Faheem
Assistant professor of anesthesiology, intensive care, and pain medicine
Tanta University
