The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Remifentanil consumption expressed in mcg.kg-1.h-1
研究概览
简要总结
Opioids analgesic are the gold standard for intraoperative pain management. Their short- and long-term adverse effect motivate anesthesiologists to explore opioid sparing strategies. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. This new randomized controlled trial (RCT) will answer the question whether an intraoperative dexmedetomidine infusion compared to placebo has a clinically significant impact on intraoperative remifentanil consumption during a laparoscopic abdominal elective surgery.
详细描述
Opioids analgesic have been used for intraoperative pain management for decades. They are the gold standard for pain relief due to their high efficacy. However, the short- and long-term adverse effects of opioids motivate anesthesia teams to explore opioid sparing strategies employing a combination of analgesics and adjuvants via continuous infusions. Opioid tolerance and opioid-induced hyperalgesia can lead to dose escalation of prescribed opioids and poor pain control.
Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. Other post-procedure applications such as reduction of cough, agitation and shivering have been described.
Many trials have studied the impact of intraoperative dexmedetomidine on post-operative pain scores, post-operative opioids consumption and common side effects compared with a remifentanil intraoperative infusion. One randomized controlled trial studied the impact of a 30 min dexmedetomidine infusion on intraoperative remifentanil consumption in ASA 1-2 patients undergoing maxillofacial or cervicofacial surgeries. They found a clinically meaningful reduction of 33% of remifentanil consumption at 120 minutes in the dexmedetomidine group. This trial aims to demonstrate a similar reduction when extending to ASA 3 patients undergoing laparoscopic surgery. Furthermore, the investigators aim to evaluate patients' recovery and pain status 24h after the surgery which hasn't been done before in the context of joint dexmedetomidine and remifentanil infusion. The investigators hypothesize that patients of the dexmedetomidine infusion group will require less intraoperative remifentanil to keep the NOL-index into the prespecified range. In the PACU, lower pain score et less opioids requirements are anticipated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Laparascopic surgery (including general surgery, gynecology, urology) a small abdominal incision (less than 5 cm) will be tolerated.
排除标准
- •Patient refusal
- •Chronic use of opioids
- •Allergy to medication used in the trial
- •Pregnant or breastfeeding women
- •Contraindications to dexmedetomidine (Bradycardia, arrythmia or pace- maker, severe ventricular dysfunction)
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine 0.5 mcg/kg (adjusted body weight) ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) delivered over 10 minutes during induction of general anesthesia, followed by dexmedetomidine 0.5 mcg.kg-1.h-1 (maximum dose: 2.5mcg.kg-1)
干预措施: Dexmedetomidine (Drug)
Placebo - Normal Saline
Normal saline in volume equivalent of dexmedetomidine dose according to patient weight ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) so that the full dose is delivered is equivalent to a maximum dose of 2.5mcg.kg-1 of dexemedetomidine
干预措施: Placebo (Drug)
结局指标
主要结局
Remifentanil consumption expressed in mcg.kg-1.h-1
时间窗: From induction of anesthesia to end of surgery
Compare remifentanil consumption when using an intraoperative dexmedetomidine infusion (bolus of 0.5mcg.kg-1, than infusion of 0.5 mcg.kg-1.h-1, with a maximum dose of 2.5 mcg.kg-1) versus placebo (normal saline)
次要结局
- Total intraoperative propofol consumption (mg.kg-1.h-1)(From induction of anesthesia to end of surgery)
- Mean intraoperative blood pressure(From induction of anesthesia to end of surgery)
- Number of intraoperative episodes of high/low blood pressure(From induction of anesthesia to end of surgery)
- Number of episodes of intraoperative tachy-/bradycardia(From induction of anesthesia to end of surgery)
- Total intraoperative dose of vasopressors(From induction of anesthesia to end of surgery)
- intraoperative NOL index(From intubation to end of surgery)
- Time for extubation (in minutes)(From end of surgery to extubation)
- Morphine equivalent consumption in the post anesthesia care unit (PACU)(From PACU admission to discharge from PACU (Aldrete Score >=9 / 10))
- Pain scores using visual analogue scale (VAS) in PACU(From PACU admission to discharge from PACU (Aldrete Score >=9 / 10))
- Adverse events in PACU(From PACU admission to discharge from PACU (Aldrete Score >=9 / 10))
- Lenght of stay in PACU (in minutes)(From PACU admission to discharge)
- Pain scores using numeric rating scale (NRS) 24h post-op(post-op day 1)
- Quality of recovery (QoR) index 24h post-op(post-op day 1)
- Mean intraoperative heart rate(From induction of anesthesia to end of surgery)
研究者
Olivier Verdonck
MD, MSc, Clinical Assistant Professor, Head of Department of Anesthesiology and Pain Medecine
Maisonneuve-Rosemont Hospital