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临床试验/NCT05602428
NCT05602428已完成不适用

Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine

Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Vital signs

研究概览

简要总结

To observe the clinical effect of esketamine combined with hip capsule peripheral nerve block in elderly patients undergoing total hip arthroplasty. A total of 120 elderly patients who underwent total hip arthroplasty in our hospital from January 2020 to May 2021 were randomly divided into three groups, 40 cases in each group. The observation group A was treated with esketamine subanesthetic dose combined with hip capsule peripheral nerve block, the control group B was treated with esketamine subanesthetic dose combined with lumbar plexus block, and the control group C was treated with esketamine subanesthetic dose for general anesthesia. The onset time of anesthesia, duration of block, postoperative recovery time, postoperative extubation time, MAP and HR indexes before anesthesia (T0), during skin incision (T1), 30 minutes after the start of surgery (T2), and at the end of surgery (T3) were recorded in the three groups, and the VAS score and Ramsay score at 0.5 h, 2 h, 6 h, 12 h, and 24 h after surgery, as well as the incidence of postoperative adverse reactions were recorded in the three groups.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 60 years
  • American Society of Anesthesiology (ASA) II or III
  • No serious coronary heart disease, hypertension, diabetes and related complications, no serious liver and kidney function damage, no mental illness

排除标准

  • Allergic to ketamine
  • Abnormal coagulation function
  • Mental system diseases or cognitive dysfunction
  • Severe liver and kidney dysfunction

研究组 & 干预措施

The observation group A

Experimental

The use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block. The patients were subjected to local anesthesia and punctured through the left radial artery for invasive arterial blood pressure monitoring. Anesthesia induction: the observation group followed by intravenous injection of ketamine 0.2mg/kg, sufentanil 0.3μg/kg, Cyclophenol 0.3mg/kg, midazolam 2mg, rocuronium 0.6mg/kg. After the onset of the drug endotracheal intubation, connect anesthesia machine control breathing. Anesthesia was maintained with 1%~2% sevoflurane inhalation, remifentanil infusion rate was 0.2~0.3 μg/kg·min, sevoflurane was stopped 30 min before the end of the operation. Patient-controlled intravenous analgesia pump (PCIA) was given for postoperative analgesia. PCIA formula: sufentanil 100ug+ondansetron 8mg+ketorolac tromethamine 60mg+saline to 100ml, pump speed 2ml/h, automatic single dose 3ml, lock time 20min.

干预措施: esketamine sub-anesthetic, (Drug)

the control group B

Active Comparator

Esketamine subanesthetic dose combined with lumbar plexus block was used. The patient was placed in the healthy lateral decubitus position and ultrasound-guided puncture was performed 4 cm beside the 3rd and 4th lumbar vertebrae (Figure 1B、C). The frequency of the ultrasound probe was 2-5 MHz, and the probe was adjusted until the images below the transverse processes of the 3rd to 5th lumbar vertebrae and the psoas muscle were clearly displayed, and the needle was inserted close to the probe and retracted in the lumbar plexus, and sufentanil 0.5 μg/kg, propofol 1.5 mg/kg, and rocuronium 0.6 mg/kg were injected after no blood extraction. General anesthesia was then performed using a subanesthetic dose of esketamine and the same maintenance and postoperative analgesic measures were used as in group A.

干预措施: esketamine sub-anesthetic (Drug)

the control group C

Active Comparator

general anesthesia was performed with esketamine subanesthetic dose. The same maintenance and postoperative analgesia measures were used as in group A.

干预措施: esketamine sub-anesthetic (Drug)

结局指标

主要结局

Vital signs

时间窗: at the end of surgery (T3) 78 minutes

heart rate at the end of surgery (T3)

Visual Analogue Scale

时间窗: 24hour

Visual Analogue Scale score (0 is no pain; 0 \~ 4 is mild pain; 4 \~ 7 is moderate pain; 7 \~ 10 is severe pain)

Anesthesia indicators

时间窗: postoperative extubation time 17 minutes

Add a postoperative extubation time Outcome Measure

Ramsay sedation score

时间窗: 24hour

Ramsay score (range 0\~6 points, 1 point for insufficient sedation, 2\~4 points for good sedation, 5\~6 points for excessive sedation)

Adverse reactions

时间窗: at the end of surgery 48 hours

the incidence of postoperative delirium, nausea and vomiting, drowsiness, skin itching and other adverse reactions

次要结局

未报告次要终点

研究者

发起方
Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanhua Huo

Doctor

Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine

研究点 (1)

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