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 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

  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 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) General anesthesia

  1. Case entry status

   A total of 30 test cases were completed in this trial. The general conditions of the patients are shown in Table 1. There were no statistically significant differences in age, weight, and male-to-female ratio between the two groups.

   All of the 30 test subjects completed the test according to the protocol, and there was no withdrawal or suspension of the test.

  2. Comparison of the safety and effectiveness of the two groups of patients

   There were no adverse events or serious adverse events in the whole trial, and no serious malfunctions of the equipment occurred.

   There was no significant statistical difference in blood pressure (including SBP and DBP), heart rate, pulse oximetry, and BIS value at each observation time point between the two groups during anesthesia. There was no statistically significant difference in the patient's recovery time (see Table 2)

   3. During anesthesia, whether the two groups of patients used ephedrine and supplemented propofol, the dosage and frequency of use were not significantly different (see Table 3).

   (two) epidural anesthesia

  1. A total of 32 patients entered the observation. One patient in the control group signed an informed consent and then proposed to withdraw from the study. One patient in the experimental group was excluded because the operation time was longer than 3 hours, which was not consistent with the experimental design. Therefore, the test group contains 15 patients and the control group contains 15 patients.

   2. There was no significant statistical difference in age, weight, basal blood pressure, heart rate, and pulse oxygen saturation between the two groups (see Table 4).

  3. There was no statistically significant difference in blood pressure (SBP and DBP), heart rate, and pulse oxygen saturation at each observation point in the two groups during anesthesia. There was no significant statistical difference in anesthesia effect between the two groups of patients, and no significant statistical difference in anesthesia level (see Table 5).

  4. There was no statistically significant difference in the dose and frequency of ephedrine and 2% lidocaine between the two groups during anesthesia (see Table 6).

   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:

   1. Effectiveness evaluation:

  1. General anesthesia:

   This trial is a prospective, randomized, controlled clinical verification of the adjustable disposable continuous injector SHI3-50-10/25/35 and the Grasby3500 intravenous injection pump produced by Beijing Kelian Sublimation Applied Technology Research Institute. All 30 observation subjects completed verification according to the test plan, and there was no withdrawal or suspension of the test. From the experimental observation data, it can be seen that there is no significant statistical difference in blood pressure, heart rate, BIS value, and awakening time of patients at each time point between the two groups, reflecting whether the Grasby3500 intravenous injection pump or the adjustable disposable continuous injector ( Intraoperative anesthesia pump) SHI3-50-10/25/35 type of intravenous general anesthesia can provide a suitable depth of anesthesia, maintain the stability of the hemodynamics of patients during the perioperative period, and no serious failure of the equipment occurred during the test. Adverse events or serious adverse events occur. It is suggested that the adjustable disposable continuous injector SHI3-50-10/25/35 is safe and effective for clinical intravenous general anesthesia.

   There was one patient in the test group who needed intravenous intermittent supplementation of propofol to maintain a suitable depth of anesthesia. Although the data results were not significantly different from the control group, it suggested that the adjustability of the injection speed was limited.

  2, epidural anesthesia: In this trial, the adjustable disposable continuous infusion device SHI3-50-4/6/10 for continuous administration and intermittently divided spinal epidural supplements produced by Beijing Kelian Sublimation Application Technology Research Institute was prospective and random. , Controlled clinical verification 30 cases of observation objects completed verification according to the test protocol.

   Epidural anesthesia complications include too wide anesthesia plane, resulting in blood pressure drop and breathing difficulties, or incomplete block effect. The results of the test showed that there were no statistically significant differences in blood pressure, heart rate, and pulse oximetry between the two groups of patients at each observation point. At the same time, there were no significant statistical differences in the level of anesthesia and the effect of anesthesia between the two groups, suggesting two All methods of administration can provide satisfactory anesthesia effects, and the patient's circulation and breathing are stable during the anesthesia process, and no adverse events related to anesthesia occur. It is proved that the adjustable disposable continuous injector SHI3-50-4/6/10 is safe and effective for clinical epidural anesthesia.

   There were patients in the two groups who needed additional local anesthetics due to insufficiency of anesthesia, and there was no significant statistical difference in the number of additional cases, frequency, and dose. The reason is the deficiencies of epidural anesthesia and has nothing to do with the way of medication.

   2. 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:

  Adjustable disposable continuous injector SHI3-50-10/25/35 is used for clinical intravenous general anesthesia, which can maintain the appropriate clinical anesthesia depth, no related adverse events occurred during use, and no serious failure of the device occurred. There is no difference with the control group in terms of safety and effectiveness.    Adjustable disposable continuous infusion device SHI3-50-4/6/10 is used for continuous epidural anesthesia during epidural anesthesia. It can provide good anesthesia effect and has little effect on the patient's breathing and circulation. It has the same safety and effectiveness as the control group.

   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:

   It is recommended to increase the volume of the adjustable disposable continuous injector for intravenous anesthesia, improve the flow adjustment device, and provide more flow rate options to maintain the depth of anesthesia.   Table 1 General data of patients (±s, n=15)


  Test group

Control group

     P value

  age)

Weight (kg)

Male/female

44±7

59 ±8

4/11

45±8

63 ±7

5/10

P>0.05

P>0.05

P>0.05

 

 

 

Table 2 Changes of observation indexes at each time point during anesthesia of patients (±s, n=15)


test group

Control group

P value

Before induction of anesthesia

SBP(mmHg)

DBP(mmHg)

HR(次/分)

SpO2

BIS

 

After tracheal intubation

SBP(mmHg)

DBP(mmHg)

HR(次/分)

SpO2

BIS

 

1 minute after peeling

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

BIS

3 minute after peeling

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

BIS

 

10 minute after peeling

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

BIS

 

Suture incision

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

BIS

 

Wake up after anesthesia

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

BIS

 

Wake up time (minutes)

 

130 ±14

75±9

73 ±10

98 ±1

97±1

 

 

118 ±15

69±8

77±9

99±1

54±7

 

 

116 ±10

67 ±9

68 ±9

99±1

49±4

 

115±11

69±9

69±8

99±1

49±4

 

 

119±12

67±8

73±9

99±1

48±5

 

 

120±10

68±9

68±5

99±1

58±6

 

 

129±12

72±6

74±4

99±1

80±2

 

3.9±1.9

 

133 ±18

73±10

79 ±12

98 ±1

97±2

 

 

112±13

69±10

79±10

99±1

51±9

 

 

110±11

62±8

67±8

99±1

48±5

 

113±13

65±7

67±10

99±1

47±4

 

 

116±10

69±8

69±10

99±1

48±4

 

 

118±9

70±10

70±7

99±1

57±6

 

 

122±10

68±5

75±6

99±1

84±6

 

5.2±2.9

 

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

 

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

 

P>0.05

 

 

  Table 3 The use of ephedrine and additional propofol in patients


Test group (n=15)Control group (n=15) Pvalue

Ephedrine

Application

cases

frequency

dose

Propofol

Application cases

frequency

Total dose (ml)

 

0

0

0

 

1

3

14

 

0

0

0

 

0

0

0

 

P>0.05

P>0.05

P>0.05

 

P>0.05

P>0.05

P>0.05 

 

 

  Table 4 General information of patients (±s)


Test group (n=15)Control (n=15)P value

  age)

Weight (kg)

men and women

   SBP(mmHg)

   DBP(mmHg)

   HR(Times/min)

   SpO2

47±9

61 ±10

6/9

130±12

70±9

74±9

98 ±1

44±7

64±7

5/10

135±18

75±11

76±10

98 ±1

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

P>0.05

 

 

  Table 5 List of changes in observation indicators at each time point during anesthesia (±s)


Test group (n=15)

 

Control group (n=15)P value

Give the test volume 5 minutes

SBP(mmHg)

DBP(mmHg)

HR(次/分)

SpO2

 

Give the load for 5 minutes

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

 

Fixed anesthesia plane

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

 

Operation started

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

 

10 minutes after peeling

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

 

End of operation

SBP(mmHg)

DBP(mmHg)

HR(Times/min)

SpO2

 

Anesthesia plane

Anesthesia effect

it is good

general

 

128 ±12

73±9

76±9

98 ±1

 

 

125 ±14

70±10

80±9

99±1

 

 

125 ±12

67 ±8

68 ±7

99±1

 

 

120±10

70±6

68±10

99±1

 

 

120±12

67±10

73±9

99±1

 

 

122±10

67±9

66±7

99±1

 

T8±2

 

13

2

 

133 ±12

73±10

79 ±10

98 ±1

 

 

123±13

72±10

79±10

99±1

 

 

130±11

62±8

67±9

99±1

 

 

127±13

65±7

72±11

99±1

 

 

125±10

69±9

71±10

99±1

 

 

128±9

70±10

70±7

99±1

 

T10±2

 

13

2

 

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

 

 

P>0.05

P>0.05

P>0.05

P>0.05

 

P>0.05

 

P>0.05

P>0.05

 

  Table 6 The use of ephedrine and lidocaine in patients


Test group (n=15)Control group (n=15)P value

Ephedrine

Application

cases frequency

Dose (mg)

2% lidocaine Application

cases

frequency

Dosage (ml)

 

1

1

10

 

2

1

5

 

0

0

0

 

2

1

5

 

P>0.05

P>0.05

P>0.05

 

P>0.05

P>0.05

P>0.05


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