Evaluation of the Effect of Adding Magnesium Sulfate Infusion to Ketamine Infusion on Improvement of the Analgesic Efficacy in Cancer Breast Surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the total amount of morphine required during the first postoperative 24 hours
研究概览
简要总结
90 female patients scheduled for cancer breast surgeries will be assigned to 2 groups, each of 45. Group (K) will receive a bolus of 0.5 mg/kg ketamine with induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. Group (KM) will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. The same anaesthetic regimen will be applied to all patients. Total intraoperative fentanyl required to maintain mean blood pressure within 20% of its baseline will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. In the follow-up visits after 3 months, all patients will be assessed for neuropathic pain by DN4 questionnaire.
详细描述
90 female patients aged between 18 and 65 years, scheduled for cancer breast surgeries will be assigned to 2 groups, each of 45. Group (K) will receive a bolus of 0.5 mg/kg ketamine with induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. Group (KM) will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. The same anaesthetic regimen will be applied to all patients. Total intraoperative fentanyl required to maintain mean blood pressure within 20% of its baseline will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. In the follow-up visits after 3 months, all patients will be assessed for neuropathic pain by DN4 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study medications were prepared by a pharmacist who was not involved in the patient management or the data collection. Both the patients and the stuff involved in their management were unaware of the group assignment. Equal rates of the drug infusion and equal volumes of the administered drugs were applied to all patients to ensure double blinding of the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with class II physical status (American Society of Anaesthesiologists) ,
- •Age between 18-65 years,
- •Scheduled for breast cancer surgery (e.g. modified radical mastectomy and conservative mastectomy)
排除标准
- •Patient refusal,
- •Cardiac dysfunction (ejection fraction <45%),
- •Diabetic patients
- •Patients with uncontrolled hypertension
- •Patients have any degree of heart block
- •Patients have renal impairment (creatinine > 2 mg/dl),
- •Patients have hepatic dysfunction (transaminases > 2 times normal),
- •Patients with preexisting neurological or psychiatric disease,
- •Patients who are allergic to one of the study drugs,
- •Patients with communication difficulties,
- •Inability to use the patient controlled analgesia (PCA) device,
- •Female patients who are pregnant
- •Patients who use preoperative calcium channel blockers or narcotic drugs.
研究组 & 干预措施
ketamine group : group (k)
-Ketamine group (group K): will receive a bolus of 0.5 mg/kg ketamine during induction of anaesthesia diluted in 100 ml normal saline, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. The infusion pump concentration will be 0.6mg/ml and the rate of infusion will be 0.2 ml/kg/hour
干预措施: Ketamine (Drug)
ketamine and magnesium group: group (KM)
- Ketamine and magnesium group (group KM): will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate diluted in 100 ml normal saline over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. Each ml of the administered infusion will contain 0.6mg ketamine and 40mg magnesium and the rate of infusion will be 0.2 ml/kg/hour.
干预措施: ketamine and magnesium (Drug)
结局指标
主要结局
the total amount of morphine required during the first postoperative 24 hours
时间窗: the first postoperative 24 hours
After transferring to post-anaesthesia care unit (PACU), the IV route of each patient will be connected to a PCA device containing morphine solution (1mg/ml). This PCA device will be set to deliver a demand dose of 1ml with a lockout interval of 15 minutes and without a continuous background infusion. The primary outcome in this study will be assessed in the form of the total amount of morphine required during the first postoperative 24 hours.
次要结局
- (Visual Analogue scale) VAS scores(the first postoperative 24 hours)
- the total amount of intraoperative fentanyl consumption(during anaesthesia (intraoperative))
- Douleur Neuropathique 4 (DN4(3 months after surgery)