Effect of Dexmedetomidine Combined With Dezocine and Flubiprofen for Postoperative Intravenous Patient Controlled Analgesia After Colorectal Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dezocine consumption by patient-controlled analgesia
研究概览
简要总结
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled Analgesia (PCA) after open colorectal surgery.
详细描述
Dexmedetomidine is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing effects. Besides, Dexmedetomidine has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. Many studies had been conducted to reduce the side effect of opioid analgesic. The current trend of reducing opioid analgesic side effect is direct combination of other drugs in PCA. The advantages of this method are convenient in clinical use and preventive for side effects.
In this study, 50 patients who is undergoing elective colorectal surgery will be randomly allocated into two groups (Control group and Dexmedetomidine group). Patients in both groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.
The PCA protocol of Control group is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min. The PCA protocol of Dexmedetomidine group is dezocine 0.6mg/kg, flubiprofen 3mg/k and dexmedetomidine 6μg/kg diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing open colorectal surgery
- •Written informed consent from the patient or the relatives of the participating patient.
- •BMI:18～30kg/m2
排除标准
- •Mental illness or cannot communicate.;
- •A second operation during the study;
- •Slow-type arrhythmias or hypotension;
- •Lung infection or sleep apnea syndrome;
- •Renal failure;
- •Alcohol or drug abuse;
- •Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
- •Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history;
研究组 & 干预措施
Control Group
Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h.
干预措施: Dezocine (Drug)
Control Group
Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h.
干预措施: Flubiprofen (Drug)
Dexmedetomidine Group
Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h,dexmedetomidine 0.1μg/kg/h.
干预措施: Dezocine (Drug)
Dexmedetomidine Group
Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h,dexmedetomidine 0.1μg/kg/h.
干预措施: Flubiprofen (Drug)
Dexmedetomidine Group
Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h,dexmedetomidine 0.1μg/kg/h.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Dezocine consumption by patient-controlled analgesia
时间窗: At 24 hours after surgery
The total consumption of dezocine during 24 hours after surgery are recorded.
Change in pain score
时间窗: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).
次要结局
- Change in ramsay sedation score(At 0, 2, 4, 8, 24, 48 and 72 hours after surgery)
- The incidence rates of postoperative nausea and vomiting (PONV)(At 24 hours after surgery)
研究者
Weifeng Tu
Chief Physician
Guangzhou General Hospital of Guangzhou Military Command