Analgesic Effect of Intraoperative Intravenous S-Ketamine During Total Knee Arthroplasty Surgery:A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- at rest and movement, evaluated NRS at 24hours after surgery in the surgical ward.
研究概览
简要总结
Severe acute pain after total knee arthroplasty surgery has multiple implications for hospitals and patients, monopolising resources and affecting the quality of life. S-ketamine inhibits N-methyl-d-aspartate (NMDA) receptor activation and attenuates central sensitization associated with hyperalgesia, opioid tolerance.Therefore, the primary aim of this trial was to investigate whether s-ketamine decreases pain and opioid consumption postoperatively in adult individuals undergoing total knee arthroplasty surgery.
详细描述
Total knee arthroplasty surgery is considered a cost-effective therapy for end-stage knee osteoarthritis (KOA). With an ageing population and rising rates of obesity in the world, knee joint replacements are estimated to escalate. While joint replacement is a cost effective intervention,approximately 20% of people experience persist pain postoperatively. The surgical injury triggers a myriad of responses in the pain matrix, from sensitization of peripheral and central pain pathways to feelings of fear, anxiety and frustration.
Opioids are effective for acute postoperative pain but have numerous adverse effects. In addition, postoperative opioid treatment may pose a risk of opioid addiction.
Numerous publications state that adjuvant s-ketamine reduces pain and opioid consumption postoperatively . Whether intraoperative intravenous s-ketamine alleviates postoperative acute pain after total knee arthroplasty surgery still unclear . Therefore, a randomized, controlled, clinical study was designed to observed analgesic effect intraoperative intravenous a lower doses of s-ketamine(0.3mg/kg/h) with patients after total knee arthroplasty surgery .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical statusI-III;
- •Patients understood the study in detail and voluntarily signed the informed consent before the study;
- •Patients to be treated with total knee arthroplasty Surgery under General anesthesia;
- •Elderly patients(≥65y),regardless of gender;
- •Patients can communicate normally;
- •Patients who have no contraindications to drugs such as midazolam,fentanyl,s-ketamine.
- •7.18 kg/m2 ≤BMI≤30 kg/m2;
排除标准
- •Increased intracranial or intraocular pressure;
- •severe hypertension;
- •unwillingness the study;
- •severe psychiatric disease and mental system diseases;
- •severe respiratory diseases;
- •hyperthyroidism;
- •liver and kidney dysfunction;
- •alcohol or drug abuse;
- •allergy to midazolam,fentanyl,s-ketamine.
研究组 & 干预措施
sodium chloride (NaCl; 0.9%)
For patients in the control group,anaesthesia will be maintained with intravenous sodium chloride (NaCl; 0.9%) infusion.while anaesthesia will be maintained with propofol infusion(4-12mg/kg/h),analgesia will be maintained with remifentanil(0.15-0.3ug/kg/min).The sufentanil dose at induction and the rate of intraoperative remifentanil and propofol infusions were at the discretion of the anesthesiologist in charge of the patient. The assessment of the depth of anesthesia was based on clinical evaluation,placebo-controlled infusion will be stopped 15 minutes before the end of surgery.Propofol and remifentanil infusion will be stopped at the end of surgery.
干预措施: sodium chloride (NaCl; 0.9%) (Drug)
S-ketamine
For patients in the s-ketamine group, anaesthesia will be maintained with s-ketamine infusion（0.3mg/kg/h),while anaesthesia will be maintained with propofol infusion(4-12mg/kg/h) ,analgesia will be maintained with remifentanil(0.15-0.3ug/kg/min).The sufentanil dose at induction and the rate of intraoperative remifentanil and propofol infusions were at the discretion of the anesthesiologist in charge of the patient.The assessment of the depth of anesthesia was based on clinical evaluation.S-ketamine infusion will be stopped 15 minutes before the end of surgery.Propofol and remifentanil infusion will be stopped at the end of surgery.
干预措施: S-ketamine (Drug)
结局指标
主要结局
at rest and movement, evaluated NRS at 24hours after surgery in the surgical ward.
时间窗: the patient at 24hours after operation.
NRS = (numerical rating scale) is widely used to measure pain intensity after surgery.NRS is evaluated on a 11-point NRS (0 = no pain, 10 = worst pain imaginable)
次要结局
- at rest and movement, evaluated NRS at 2 hours after surgery in the surgical ward.(the patient at 2 hours after operation.)
- at rest and movement, evaluated NRS at 48hours after surgery in the surgical ward.(the patient at 48hours after operation)
- The cumulative Opioids consumption during the first 48h after operation(Within 48hours after surgery)
- The Opioids or non-steroid anti-inflammatory drugs total consumption during the first 48h after operation(Within 48hours after surgery)
- The number of patients who required additional analgesics during the first 48h after operation(Within 48hours after surgery)
- The incidence of PONV and adverse central nervous system (CNS) events.(at2, 24, 48hours after operation.)
研究者
Ling Dong
clinical professor
Qianfoshan Hospital