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 response, changes in BIS value, and recovery time.
3 The evaluation criteria for epidural anesthesia patients include cardiovascular system response, anesthesia effect and anesthesia level.
二 Safety evaluation:
1. No serious adverse reactions or adverse events occurred during the trial;
2. There was no serious failure of the product during the test.
3. The overall performance of the test equipment meets or exceeds the performance of similar products.
Clinical trial results:
1. Case enrollment status:
A total of 60 observation cases were completed in this trial. The first patient was enrolled on December 24, 2008, and the last patient was enrolled on January 20, 2009. The records of all the included cases are complete.
All 60 test subjects completed the test according to the protocol, without withdrawal or suspension of the test, no other adverse events or serious adverse events.
2. Basic situation analysis of the case:
?、? The basic data of 60 cases are shown in Table 1.
Table 1. Cases in the group
| Item | General | anesthesia | ||
| group | Epidural | anesthesia | group | |
| Gender (Male/Female) | 4/11 | 7/8 | 6/9 | 6/9 |
| Age (years) | 50.7±12.6 | 45.9±12.2 | 38.5±13.4 | 47.5±13.5 |
| Weight (Kg) | 66.5±12.9 | 67.3±11.0 | 67.9±9.8 | 65.3±13.9 |
| Height (cm) | 164.3±8.3 | 167.2±6.9 | 166.4±6.8 | 165.4±7.7 |
Mean±SD
There were no statistically significant differences in gender, age, weight, and height between the observation group and the control group in the general anesthesia group and epidural anesthesia group.
Among the 30 observation cases in the general anesthesia group, 4 male patients in the control group accounted for 26.7%, and 11 female patients accounted for 73.3%; the average age was 50.7 years; the average weight was 66.5 kg; the height was 164.3 cm; 7 male patients in the observation group accounted for 46.6%. Female 8 accounted for 53.4%; average age was 45.9 years; average weight was 67.3 kg; height was 167.2 cm. Of the 30 study cases in the epidural anesthesia group, 6 male patients in the control group accounted for 40%, and 9 female patients accounted for 60%; the average age was 38.5 years; the average weight was 67.9 kg; the height was 166.4 cm; 5 male patients in the observation group accounted for 33.3 %, female 10 accounts for 66.7%; average age is 47.5 years old; average weight is 65.3 kg; height is 165.4cm.
⑵. Operation time, anesthesia time, extubation time and patient recovery time are shown in Table 2
Table 2. Operation time, anesthesia time, extubation time and patient recovery time
| Item | General anesthesia group | Epidural anesthesia group | ||
| Control group | observation group | control group | observation group | |
| Operation time (min) | 126.9±58.8 | 127.7±46.0 | 71.5±33.4 | 83.1±46.4 |
| Anesthesia time (min) | 162.6±75.9 | 164.1±54.3 | ||
| Extubation time (min) | 4.7±2.0 | 5.5±3.2 | ||
| Wake up time (min) | 3.3±1.8 | 4.4±2.1 | ||
Mean±SD
Compared with the control group, the observation group in the general anesthesia group showed no statistically significant differences in operation time, anesthesia time, extubation time and recovery time. In the general anesthesia group, the operation time of the control group was 126.9 min, the anesthesia time was 162.9 min, the extubation time was 4.7 min, and the recovery time was 3.3 min; the observation group in the general anesthesia group was 127.7 min, and the anesthesia time was 164.1 min. The tube time is 5.5min, and the wake-up time is 4.4min. The operation time of the control group in the epidural anesthesia group was 71.5 minutes; the operation time of the observation group was 83.1 minutes. 3. Effectiveness observation
?、? The hemodynamic changes and bispectral index (BIS) comparison of patients in the general anesthesia group are shown in Table 3 (attached).
?、? The hemodynamic changes and the comparison of nerve segments blocked by anesthesia in the epidural anesthesia group are shown in Table 4 (attached).
?、? The frequency and dose comparison of ephedrine and propofol used by patients in the general anesthesia group are shown in Table 5 (attached).
?、? The frequency and dose comparison of ephedrine, sedatives, opioids and local anesthetics in the epidural anesthesia group are shown in Table 6 (attached).
Adverse events and side effects found in clinical trials and their treatment:
All patients in the general anesthesia group and epidural anesthesia group had no adverse events.
Clinical trial effect analysis: This test observes the application of the adjustable disposable continuous injector (SHI3-50) in clinical anesthesia by subjects. The general anesthesia group compares its effectiveness and safety with the internationally recognized well-known R&D manufacturer Freseniu For comparison with the anesthesia infusion concerto workstation of Sri Lanka, the effectiveness and safety of the epidural anesthesia group were compared with our traditional single-time supplemental administration method. There are 30 observation subjects in each group. Each group of 30 observation objects were tested according to the protocol. In each group, there were 30 cases for effectiveness analysis and 30 cases for safety analysis. The number of analyzed population meets the design requirements.
Effectiveness evaluation:
All observation subjects successfully completed the surgical procedure. The patients in the general anesthesia group used the domestically-made adjustable disposable continuous injector (SHI3-50-10/25/35) and the Fresenius Concerto workstation. The hemodynamic changes and EEG of the two groups during the operation were compared. There were no statistically significant differences in spectrum index (BIS), recovery time, ephedrine use times and doses, and additional propofol times and doses; patients in the epidural anesthesia group used a domestic adjustable single-use continuous injector (SHI3 -50-4/6/10) Compared with the traditional single supplemental administration method, the hemodynamic changes during the operation of the two groups of patients, the adjustment of the anesthesia block segment, the frequency and dosage of ephedrine use, and sedative drugs There were no statistically significant differences in the frequency and dosage of use and the frequency and dosage of opioid use.
Safety evaluation:
A total of 60 patients in the two groups have successfully completed the surgical process. During the observation process, no adverse events occurred, no serious obstacles occurred, and the performance of the observation group was not significantly different from that of the control group.
Clinical trial conclusion: The adjustable disposable continuous injector (SHI3-50) produced by Beijing Kelian Shenghua Applied Technology Research Institute and the anesthesia concerto infusion workstation and epidural tradition produced by the internationally recognized famous research and development manufacturer Germany Fresenius The administration methods were compared at the same time. During the use of clinical anesthesia, the drug infusion was basically accurate, no adverse events or serious obstacles occurred, and the performance-related monitoring indicators were not statistically different from those of the control group, so it is suggested that they can be adjusted The disposable continuous injector (SHI3-50) can be safely and accurately used for some simple clinical anesthesia.
Indications, scope of application, contraindications and precautions:
Continuous infusion of intravenous liquid is suitable for the maintenance of general anesthesia in the operating room; continuous infusion of local anesthetics is suitable for the maintenance of continuous epidural anesthesia in the operating room.
Problems and suggestions for improvement:
The adjustable disposable continuous injector (intraoperative anesthesia pump) recommended for intravenous anesthesia can increase the volume of the container and suit the needs of different operation times.
Beijing Kelian Shenghua Medical Technology Co., Ltd 京ICP備05070151號 互聯(lián)網(wǎng)藥品信息服務(wù)資格證書號：（京）-非經(jīng)營性-2017-0043