Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia by Remifentanil Infusion
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
研究概览
简要总结
The concept of Enhanced Recovery After Surgery(ERAS) has been prevalent in recent years. In the ERAS guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. Propofol-remifentanil based total intravenous anesthesia (TIVA) can provide quicker emergence and decreased post-operative nausea and vomiting. However, the prescription of opioid (especially remifentanil) may induce opioid-induced hyperalgesia (OIH) and increase the requirement of analgesics. Previous studies provided some strategies to prevent OIH. The purpose of this study is to investigate the effect of adding remifentanil(1 mcg/kg) after emergence and endotracheal extubation in breast cancer females receiving breast surgery under propofol-remifentanil based TIVA for the prevention of OIH.
详细描述
- After obtaining informed consent, patients will be randomized into two groups.
- All patients receive remifentanil-propofol based TIVA and Bispectral index (BIS) monitor during breast surgery. In the end of surgery, intravenous NSAID(keto) 30mg and local anestehsia (Marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain.
- group R(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube
- group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube
- In post-anesthesia room: record the numerical rating scale (NRS); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting
- In ward: record the numerical rating scale (NRS) and total analgesics consumption
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject's ASA (American Society of Anesthesiologists) Physical Status Classification: I (A normal healthy patient)~III(A patient with severe systemic disease)
- •Subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(TIVA)
排除标准
- •Subject's ASA (American Society of Anesthesiologists) Physical Status Classification >3
- •Subject doesn't receive total-intravenous anesthesia(TIVA) during surgery
- •Subject has psychiatric disease
- •allergic to opioid or propofol
- •History of alcoholism
- •History of drug abuse
研究组 & 干预措施
remifentanil
After emergence and extubation of endotracheal tube, remifentanil 1mcg/kg were diluted with 0.9% saline to 50 ml, added in IV bag, and drip for 30 minutes.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
时间窗: 30 minutes
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
The amount analgesic requirement in post-anesthesia room (PAR)
时间窗: 30 minutes
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics during surgery. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by record additional analgesics amount (rescue medication, mg) in PAR
次要结局
- post-operative pulse oximeter in post-anesthesia room (PAR)(0 minutes)
- postoperative pulse oximeter in post-anesthesia room (PAR)(30 minutes)
- degree of post-operative nausea in post-anesthesia room (PAR)(30 minutes)
- degree of post-operative vomiting in post-anesthesia room (PAR)(30 minutes)
- post-operative blood pressure in post-anesthesia room (PAR)(0 minutes)
- post-operative systolic blood pressure in post-anesthesia room (PAR)(30 minutes)
- post-operative diastolic blood pressure in post-anesthesia room (PAR)(30 minutes)
- post-operative heart rate in post-anesthesia room (PAR)(30 minutes)
- Numerical Rating Score (NRS) for pain score in ward(24 hours after transferring to ward)
- total analgesics requirement in ward(24hr after transferring to ward)
研究者
Wei-Hung Chan
Principal Investigator
Tri-Service General Hospital