Remifentanil and Hyperalgesia: Gradual Withdrawal Versus Immediate Discontinuation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- First demand of postoperative analgesic
研究概览
简要总结
Modern anesthesia has made a lot of progress, however, postoperative pain remains one of the major problems associated with patient discomfort, prolonged hospital stay and increased health care costs.
Remifentanil is an ultra-short-acting phenylpiperidine opioid analgesic with high lipid solubility and a rapid onset of effect.
Recently, opioid use has also been associated with postoperative opioid-induced hyperalgesia or acute opioid tolerance. An immediate discontinuation of remifentanil has been associated to increased postoperative pain levels.
We would like to investigate whether a gradual post-operative withdrawal of remifentanil is indeed associated with less immediate pain compared to after an abrupt withdrawal in surgical patients undergoing minor surgery.
详细描述
Modern anesthesia has made a lot of progress, however, postoperative pain remains one of the major problems associated with patient discomfort, prolonged hospital stay and increased health care costs.
Remifentanil is an ultra-short-acting phenylpiperidine opioid analgesic with high lipid solubility and a rapid onset of effect.
It is rapidly metabolized by non-specific blood and tissue esterases, which also ensures rapid recovery. Remifentanil can be given in high doses and is easily titratable. Due to its rapid elimination, a bridge to post-operative analgesia is a necessity when using this drug.
Recently, opioid use has also been associated with postoperative opioid-induced hyperalgesia or acute opioid tolerance. An immediate discontinuation of remifentanil after digestive surgery has been associated to increased postoperative pain levels.
Studies have been done to investigate this phenomenon. Gradual withdrawal of remifentanil seems to be associated with less pain in a rodent population. (4) A recent study by Norwegian colleagues in a human population evaluating two types of pain stimuli seems to confirm this in healthy volunteers. (5) The investigators would like to investigate whether a gradual post-operative withdrawal of remifentanil is indeed associated with less immediate pain compared to after an abrupt withdrawal in surgical patients undergoing minor surgery.
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, Investigator, Outcomes Assessor)
盲法说明
Patients, the anesthesiologist and an external observer will be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing a thyroid surgery
- •male/female
- •from the age of 18 until 65
- •ASA physical status of I-III
- •Knowledge of French, English or Dutch is required in order to be enrolled in this study.
排除标准
- •Pregnancy
- •hypo-/hyperthyroidism
- •gastro-duodenal ulcer
- •allergy or contraindications to one of the study drugs
- •renal insufficiency
- •liver insufficiency
- •neuropsychiatric disturbance
- •history of drug and alcohol abuse
- •preoperative analgesic drug use
研究组 & 干预措施
Remifentanil
Remifentanil TCI: gradual withdrawal: reduction of 30% / 15 mins (2 -> 1.4 -> 1 -> 0.7-> 0.5 -> 0.35 -> 0.25 -> 0 ng/ml)
干预措施: Remifentanil (Drug)
NaCl 0.9%
Remifentanil abrupt discontinuation / NaCl 0.9% (control group with a reduction of 30% /15 mins) (2 -> 1.4 -> 1 -> 0.7-> 0.5 -> 0.35 -> 0.25 -> 0 ng/ml)
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
First demand of postoperative analgesic
时间窗: 24 hours postoperative
the first demand of post-operative analgesic will be compared in both groups.
次要结局
- Pain evaluation(24 hours postoperative)
- Patient satisfaction(24 hours postoperative)
研究者
Sarah Saxena
Dr
Université Libre de Bruxelles