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KSH medical continuous injector for postoperative analgesia
  Department of Anesthesiology, West China Hospital, Sichuan University    Yin Yan Liu Bin Hong Ying Yang Bangxiang In postoperative analgesia, patient-controlled analgesia (PCA) technology is timely, quick and convenient, follows individual differences, maintains a relatively stable minimum effective analgesic concentration (MEAC), good analgesic effect, and postoperative The advantages of fewer complications, high safety factor, and low incidence of side effects will gradually replace the traditional intermittent intramuscular injection [1,2,3]. "According to the route of administration, PCA is divided into epidural administration (PCEA), intravenous administration (PCIA), and subcutaneous administration (PCSA). The basic modes of administration include continuous infusion, patient-controlled administration, and patient-controlled administration based on continuous background infusion.    There are many types of PCA pumps [4]. In recent years, we have mainly used Australian Go Medical PCA pumps and American Microject electronic pumps. Practice has proved that analgesic pumps can provide better analgesic effects, reduce patient anxiety, and improve patient satisfaction. However, as a first-line analgesic, the potential life-threatening respiratory depression of opioid analgesics cannot be ignored, and it is the biggest hidden danger of PCA application.    In this study, domestically made KSH pump was used to inject tramadol + cosifane subcutaneously/venously to evaluate the postoperative analgesic effect, side effects and performance of KSH pump.    materials and methods Participants 62 patients with general surgery, urology, and general breast, aged 18-83 years, male:female = 36:24, ASA I~II grade, all underwent intravenous inhalation combined general anesthesia, and were randomly divided into intravenous administration (PCIA) group (30 Example) and subcutaneous administration (PCSA) group (32 cases). Exclude severe damage to liver and kidney function, digestive ulcer bleeding, coagulopathy, and non-steroidal anti-inflammatory drug allergy.    Method PCA formula: 800mg of tramadol + 32mg of cosaifen diluted with 0.9% saline to 100ml (tramadol concentration 8mg/ml, cosaifen concentration 0.32mg/ml). The analgesia pump uses the domestic KSH medical continuous infusion device. In the PCIA group, the intravenous infusion was started at the end of the operation, and the PCSA group was infused subcutaneously before the suture at the end of the operation, followed by a special person. Index 12, 24, 48h pain VAS score (0 is no pain, 10 is severe pain), sedation VAS score (0 is awake, 10 is lethargy), comfort VAS score (0 is comfortable , 10 points for very discomfort), anal exhaust time, side effects, dosage, time with pump.    Statistical analysis The count data are expressed as mean±standard deviation, the comparison between groups is by t test, and the count data is by x2 test. P<0.05 is statistically significant.    Experimental equipment KSH medical continuous injector provided by Beijing Kelian Shenghua Company, with a capacity of 100 ml and a flow rate of 2 ml/hour.   Result   Patient's general condition (table 1) and the average value of postoperative indexes (table 2)   Table 1 General conditions of patients Group gender (men and women) age (year old) Body mass index (kg/m2) Operation time (h) PCIAGroup 19/11 53.7±13.6 24.7±1.6 3.05±0.23 PCSAGroup 17/15 53.7±15.5 25.1±1.3 3.32±0.31     Comparison between the two groups P>0.05    There were no significant differences in gender, age, body mass index, and operation time between the two groups.    Table 2 The average value of various indexes after 60 patients Pain VAS score 12h after operation 2.97±0.97 24h after operation 2.5±0.66 48h after operation 2.02±0.87 Sedation VAS score 12h after operation 2.86±0.8 24h after operation 2.44±0.7 48h after operation 2.06±0.84 Moderate VAS score 12h after operation 2.73±0.71 12h after operation 2.44±0.7 48h after operation 2.0±0.85 Dosage (ml) 76.75±19.8 With pump time (h) 71.34±27.91 Anal exhaust time (h) 62.17±12.92       There were no significant differences in pain scores, sedation scores, and comfort scores between the two groups at 12h and 24h after surgery. At 48h after surgery, the pain scores in the PCSA group were significantly lower than those in the PCIA group (Table 3).   Table 3 Comparison of postoperative pain score, sedation score, comfort score and anal exhaust time between the two groups   pain VAS score Calm VAS score Comfortabl
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Clinical verification report of exclusive patented product (2)
  Beijing Hospital of Ministry of Health Zuo Mingzhang Hua Zhen Duan Hongjun Zhou Ju et al    Clinical trial method (including the setting of control group if necessary):    The purpose of this experiment is to observe the effectiveness and safety of the subjects using the adjustable disposable continuous infusion device in clinical anesthesia with the anesthesia infusion concerto workstation produced by Fresenius Company as a control. The subject was an elective surgical patient who planned to undergo intravenous general anesthesia and epidural anesthesia in Beijing Hospital.    General anesthesia plan:   1) The patient enters the operating room, opens the peripheral vein, and routinely monitors non-invasive blood pressure, electrocardiogram, pulse oximetry and BIS value. 2) 30 patients were randomly divided into the test group (adjustable disposable continuous infusion group, SHI3-50-10/25/35 type) and the control group (Fresenius Company's Anesthesia Infusion Concerto Workstation), each Group 15 cases. 3) All patients underwent rapid induction of anesthesia. After intravenous administration of sufentanil 0.2ug/kg, propofol 1.5-2.5mg/kg, rocuronium 0.6mg/kg, endotracheal intubation was performed and an anesthesia machine was connected Mechanical ventilation, continuous intravenous pumping of propofol and sufentanil, and use of Fresenius’ anesthesia infusion concerto workstation (control group) or (SHI3-50-10/25/35 type) for propofol respectively. Type disposable continuous infusion device (test group) for continuous pumping. Both groups of sufentanil were pumped by (Fresenius Company Concerto Anesthesia Workstation), and the anesthetic infusion was adjusted according to the needs of the operation and the patient's blood pressure and heart rate. Speed, add muscle relaxants or propofol intermittently to maintain the depth of anesthesia BIS value 40-60.   4) Data recording: Record the patient's blood pressure, heart rate, SpO2, BIS value and the patient's wake-up time (the time from the end of the operation to the opening of the eyes) before the induction of anesthesia and during the perioperative period.    Epidural anesthesia plan:   1) The patient enters the operating room, opens the peripheral vein, and routinely monitors non-invasive blood pressure, electrocardiogram, and pulse oximetry. 2) Select 30 patients who intend to undergo epidural anesthesia for lower abdomen or lower extremity surgery, and randomly divide them into the experimental group (adjustable single-use continuous injector administration group, SHI3-50-4/6/10) and Control group (single intermittent administration group), 15 cases in each group. 3) The patient underwent a lumbar intervertebral puncture, an epidural tube was inserted, and a pre-tested amount of 2% lidocaine 3-5ml was given to rule out the possibility of general spinal anesthesia. After 10 minutes, the corresponding 0.75% Luo was given according to surgical needs. The pivacaine load was adjusted to the level of anesthesia to meet the surgical requirements. Intraoperative epidural anesthesia maintenance method: the experimental group used an adjustable disposable continuous injector (SHI3-50-4/6/10) to continuously pump 0.75% ropivacaine into the epidural space, according to surgical needs The appropriate pump injection rate was selected, and the control group followed routine operations with intermittent epidural bolus injections of 0.75% ropivacaine according to surgical needs.   4) Data recording: record the patient's anesthesia level, intraoperative blood pressure, heart rate, SpO2 and anesthesia effect (assisted use of sedatives, opioid anesthetics and forced change of anesthesia).    Statistical methods and evaluation methods used:    Use SPSS13.0 for statistical analysis, and the data is entered, compared, and corrected twice until it is correct. P<0.05 is considered statistically different.   (1) Describe the basic situation of the test case.   (2) According to the distribution characteristics of the data, the paired sample t-test method was used to detect the basic condition and completion status of the enrolled patients, the patient's vital signs, BIS changes, surgical status and occurrence of adverse events during the perioperative period.    Statistical analysis content:   (1) Basic data and completion status of the enrolled cases.   (2) Basic information about surgery.   (3) The patient's vital signs during the perioperative period.   (4) The patient's perioperative BIS status and recovery time.   (5) The patient is anesthetized to block the nerve segment.   (6) The patient's administration of other drugs during the operation.   (7) An adverse event occurred.    Clinical evaluation criteria:   一 Effectiveness evaluation:   1 Compared with the control group, there is no statistical difference in meeting the clinical anesthesia effect index.   2 The evaluation criteria for patients with general anesthesia include cardiovascular system
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Clinical verification report of exclusive patent product (1)
  Beijing Chaoyang Hospital Affiliated to Capital Medical University Yue Yun Wu Di Wu Anshi Rui Yan et al    Clinical trial method (including the setting of control group if necessary):    The purpose of this test is to compare with common clinical methods to verify the safety and effectiveness of the adjustable disposable continuous injector in clinical general intravenous anesthesia and epidural anesthesia. The subject was an elective surgical patient who was planned to undergo intravenous general anesthesia and epidural anesthesia in Beijing Chaoyang Hospital.    1. General anesthesia plan:    This trial is a prospective, randomized, controlled clinical verification. The subject was a patient who was scheduled to undergo elective surgery and required intravenous general anesthesia in Beijing Chaoyang Hospital, Capital Medical University. Routinely monitor patients' non-invasive blood pressure (systolic and diastolic blood pressure, SBP, DBP), electrocardiogram (heart rate, HR), pulse oxygen saturation (SpO2) and BIS value. All patients underwent rapid induction endotracheal intubation and intravenous administration of midazolam 0.03-0.04mg/kg, propofol 1-2mg/kg, rocuronium 0.8-1.0mg/kg, sufentanil 0.2ug/kg , Followed by endotracheal intubation, mechanical ventilation with an anesthesia machine, continuous intravenous pumping of propofol and remifentanil, intermittent addition of actosone or propofol, and adjustment of the anesthetic infusion speed according to blood pressure, heart rate, and BIS value , Maintain a proper depth of anesthesia, and maintain the BIS value at 40-60. Both groups of remifentanil were pumped by Grasby3500; the control group propofol was pumped by Grasby3500 continuously, and the test group propofol was pumped by SHI3-50-10/25/35 adjustable disposable continuous injector continuous pump Into. At the last stitch of the surgical stitch, the pumping of propofol and remifentanil was stopped, and the patient's recovery time was observed. The changes in blood pressure, heart rate, SpO2 and BIS values ​​at various points before and during the anesthesia induction and the patient's recovery time after the operation were recorded. Record whether ephedrine was used during the operation and its dosage and frequency, and whether to add propofol and its dosage and frequency in a single time.   2, epidural anesthesia The patients who were planned to undergo elective surgery with epidural anesthesia in Beijing Chaoyang Hospital affiliated to Capital Medical University were selected and randomly divided into the experimental group: adjustable disposable continuous injector SHI3-50-4/6/10 group and control group : Routine intermittent administration group. Anesthesia: The patient enters the operating room, opens the peripheral vein, and routinely monitors non-invasive blood pressure, electrocardiogram, and pulse oxygen saturation. The lumbar puncture between 1 and 2 was performed, and a tube was placed in the epidural space. 2% lidocaine 4ml was used as the test amount to exclude general spinal anesthesia, and the post-preload amount (2% lidocaine 8-10ml). The experimental group used an adjustable disposable continuous infusion device SHI3-50-4/6/10 continuous epidural pumping local anesthetics, and the control group was administered intermittently in the epidural space according to routine operations. If the effect of anesthesia is incomplete, add local anesthetic through the epidural space. Record the patient's basic non-invasive blood pressure, electrocardiogram, pulse oximetry value and changes in blood pressure, heart rate, SpO2 at each observation point during the operation, record the anesthesia level, and evaluate the anesthesia effect at the end of the operation. Record whether ephedrine was used during the operation and the dosage and frequency, and whether to add 2% lidocaine in a single time and the additional dosage and frequency. The anesthesia effect was evaluated according to the muscle relaxation and analgesic effect.    Statistical methods and evaluation methods used:    Data statistical processing uses SPSS11.5 software, measurement data uses t-test method, uses two-sided test, count data uses chi-square analysis, P value less than or equal to 0.05 is considered to be statistically significant.    Statistical analysis content:   (1) Basic data and completion status of the enrolled cases.   (2) The patient's vital signs during the perioperative period.   (3) The patient's perioperative BIS status and recovery time.   (1) The nerve block level of the patient's anesthesia.   (2) Evaluation of anesthesia effect.   (3) The patient's administration of other drugs during the operation.   (7) An adverse event occurred.    Clinical evaluation criteria:   一 Effectiveness evaluation:    1. Compared with the control group, there is no statistical difference in meeting the clinical anesthesia effect index.   2. The evaluation criteria for patients with general anesthesia
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