Comparing Analgesic Requirements in Patients Receiving Nuss Operation Using Remifentanil or Dexmedetomidine as Anesthetic Adjuvants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Nowadays, general anaesthesia is carried under "balanced anesthesia technique" in which many anesthetic adjuvants are used simultaneously, including opioid analgesics in order to reduce the amount of inhalation agents. The most popular adjuvants used are remifentanil, which is an opioid analgesic, and dexmedetomidine. Both of these agents are short acting, can be infused with targeted concentrations, excreted shortly from the body with stable hemodynamics.
Remifentanil, when infused for more than 2 hours, causes hyperalgesia to increase the amount of pain postoperatively as well as the amount of opioid analgesics. However, dexmedetomidine does not cause hyperalgesia and is known to have an opioid -sparing effect. In our center.
In this study, we aim to compare the effects of remifentanil and dexmedetomidine on postoperative pain in patients undergoing Nuss procedure, which is a very painful operation on the chest wall.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged >20
- •Patients undergoing Nuss bar operation (pectus excavatum repair surgery)
- •American Society of Anesthesiologists classification I ~ III
排除标准
- •Drug abuse history
- •Chronic pain in need of continuous opioid analgesics administration
- •History of psychiatric diseases
- •Preoperative bradycardia (heart rate < 50/min) or arrythmia
- •Cardiac diseases other than diabetes or hypertension - coronary artery disease, ischemic heart disease
- •Moderate liver or kidney dysfunction
- •Pregnant or breast feeding women
- •Hypersensitivity to the study drugs
- •Patients who do not agree to participate
研究组 & 干预措施
Remifentanil group
In both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted Minimal Alveolar Concentration (MAC). As explained above, remifentanil is infused with Target Controlled Infusion pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia. Remifentanil is usually infused with the effect site concentration of 2.0 to 6.0 ng/ml during general anesthesia. If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased. At the end of the surgery when skin closure starts, remifentanil infusion will be stopped.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine group
In both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted MAC (Minimal Alveolar Concentration). As explained above, dexmedetomidine is infused with syringe pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia. Dexmedetomidine is loaded for 10 minutes in 1mcg/kg, and then infusion rate is set between 0.4 to 0.6mcg/kg/hour for this study. If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased. At the end of the surgery when skin closure starts, dexmedetomidine infusion will be stopped.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: Between 24~48 hours postoperatively.
Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
次要结局
- Amount of fentanyl used postoperatively at the recovery unit(At 60 minutes after the end of surgery)
- Time needed for postoperative rescue opioid analgesics(At 60 minutes after the end of surgery)
- Amount of remifentanil or dexmedetomidine used intraoperatively(Immediately at the end of the surgery)
- Intraoperative hemodynamic change: Systolic blood pressure(At the end of the surgery, average of 90minutes after the induction of anesthesia)
- Intraoperative hemodynamic change: Diastolic blood pressure(At the end of the surgery, average of 90minutes after the induction of anesthesia)
- Intraoperative hemodynamic change: mean blood pressure(At the end of the surgery, average of 90minutes after the induction of anesthesia)
- Amount of postoperative intravenous patient controlled analgesics (PCA) used(At 60 minutes after the end of surgery)
- Intraoperative hemodynamic change: heart rate(At the end of the surgery, average of 90minutes after the induction of anesthesia)
- Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia(Intraoperatively)
- Postoperative complications(Between 24~48 hours postoperatively)
研究者
Jung Min Koo
Principal Investigator
Seoul St. Mary's Hospital