Is Dexmedetomidine Effective at Reducing Pain Scores and Opioid Consumption in Coronary Artery Bypass Grafting (CABG) Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Visual analog pain (VAS) scores at 6, 12, 18, and 24 hours post-surgery
研究概览
简要总结
The purpose of this study is to determine whether adjuvant intravenous dexmedetomidine infusion starting after induction of general anesthesia can provide superior pain management (decrease pain scores) and decrease opioid administration, without increasing nausea/vomiting, compared to patients receiving only opioid and acetaminophen for the patients which going through coronary artery bypass grafting (CABG)?
详细描述
Coronary artery bypass grafting (CABG) involves a median sternotomy and subsequent surrounding surgical dissection. Resulting tissue damage can lead to neurogenic inflammation and release of inflammatory mediators that promote acute postoperative pain . Given the location of the incision, uncontrolled acute postoperative pain after CABG can be associated with significant pulmonary complications . Additionally, acute pain activates the sympathetic nervous system which can have deleterious effects on multiple organ systems including the cardiovascular, gastrointestinal, and endocrine systems .
Dexmedetomidine is a sympatholytic agent acting on the alpha2 adrenergic receptor. It was originally used as an anxiolytic and sedative agent perioperatively and in the intensive care unit (ICU) by decreasing adrenergic response in the locus coeruleus and, thus, indirectly increasing gamma-aminobutyric acid (GABA) neurons downstream .
The use of perioperative dexmedetomidine has expanded; it has been studied as part of multimodal analgesic regimens as well as an adjuvant analgesic agent. It can directly work on the peripheral nervous system and inhibit C fibers and Aδ fibers to attenuate peripheral transmission of nociception . Within the central nervous system, dexmedetomidine inhibits adrenergic nociception transmission from the locus coeruleus through the spinal cord, which in turn prevent the release of nociceptive neurotransmitters and biochemicals at the presynaptic membrane . Also, alpha receptor agonism at the presynaptic membrane inhibits the release of norepinephrine and prevents nociceptive signals to the brain . Given its action at multiple sites within the nociceptive pathway, dexmedetomidine can be administered via various modalities including intravenous, intramuscular, neuraxial, peripheral nerve block, and topical.
Given its sympatholytic effect, reported side effects of dexmedetomidine are hypotension and bradycardia. In a meta-analysis of the safety of dexmedetomidine in cardiac surgery patients done by Wang et al., there was 3.4 times increased incidence of bradycardia with patients on dexmedetomidine compared to the control; however, there was no statistically significant difference in hypotension . Bradycardia occurs more often when dexmedetomidine is infused at 0.75-1 mcg/kg/hr than at 0.5mcg/kg/hr . The meta-analysis included publications that incorporated a loading dose prior to an infusion at a set dose; high plasma level of dexmedetomidine has been associated with cross reactivity with alpha1 stimulation and subsequent vasoconstriction resulting in hypertension and reflex bradycardia. However, elimination of the loading dose has been shown to eliminate the hemodynamic effect . Any intraoperative bradycardia or hypotension can be treated with anticholinergics and vasoactive agents, respectively, without postoperative bradycardia, hypotension, or related complications .
Compared to conventional opioid analgesia for acute postoperative pain, dexmedetomidine analgesia has limited adverse impact on the cardiovascular, pulmonary, and gastrointestinal systems . Perioperative dexmedetomidine has consistently demonstrated improved acute postoperative pain and reduced narcotic requirement in noncardiac surgeries including open and laparoscopic abdominal, open and laparoscopic gynecological, and neuro surgeries compared to traditional opioid therapy .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be between 18 years old and 100 years old. Both men and women will be eligible for this study. We will aim to have approximately 50% men and 50% women. People of all races and ethnic origins are eligible.
- •Patients should be undergoing CABG (coronary artery bypass grafting ) under general anesthesia with CPB (Cardiopulmonary bypass).
排除标准
- •Patients will be excluded who are receiving valve replacement with CABG, Class I emergent CABG, receiving regional anesthesia, clinically significant preoperative neurologic, cardiac, pulmonary, renal, or hepatic disease that cannot tolerate dexmedetomidine infusion, or reported allergy to dexmedetomidine. People taking chronic opioid will also be excluded from the study.
研究组 & 干预措施
Control Group
Intravenous normal saline at a standard dose of 0.5mcg/kg/hr continued to postop until extubation.
干预措施: Saline (Drug)
Dexmedotimidine Group
Intravenous dexmedetomidine infusion started after induction at a standard dose of 0.5mcg/kg/hr and continued until extubation.
干预措施: Dexmedetomidine Injectable Solution (Drug)
结局指标
主要结局
Visual analog pain (VAS) scores at 6, 12, 18, and 24 hours post-surgery
时间窗: measured at 6, 12, 18, and 24 hours post-surgery
Pain scores are measured by asking the patients to rank their pain from 1 to 10
Total opioid consumption in the first 24 hours after surgery (Oral morphine equivalents)
时间窗: 24 Hours post surgery
the totalOral morphine equivalent dose of Opioids received by the patient 24 hour after the surgery is calculated
次要结局
- Postoperative AKI based on AKIN(during Hospital Stay)
- Incidence of pruritus (Percent of patients)(24 hours Post Surgery)
- Incidence of intraop hypotension(During Surgery)
- Incidence of post-operation nausea and vomiting (PONV) (treatment with anti-emetic) in the first 24 hours(24 Hours Post Surgery)
- Incidence of atrial fibrillation(during Hospital Stay)
- Total Acetaminophen intake(24 Hours post surgery)
- Total NSAID intake(24 hours Post Surgery)
- Hospital length of Stay(During Hospital Stay)
- Incidence of intraop bradycardia(During Surgery)
- Vasoplegia(during Hospital Stay)
- Hospital Length of Stay(During Hospital Stay)
研究者
Sandeep Krishnan
Associate Professor of Anesthesiology
Wayne State University
