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Purpose: This study aimed to find a quick and timely way to investigate the individual variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries. Methods: 120 female patients receiving elective surgery under general anesthesia were recruited into this study. At the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.
Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil group | Grouped by intravenous injection of sufentanil at the time of anesthesia induction | ||
| Fentanyl group | Grouped by intravenous injection of fentanyl at the time of anesthesia induction | ||
| Saline group | Grouped by intravenous injection of saline before the time of anesthesia induction |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Pressure Pain Threshold | According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics | 10 minutes after the procedure |
| Mean Value of Narco-trend Index | According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state. | 10 minutes after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure | According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics | 10 minutes after the procedure |
| Mean Heart Rate | According to the measurement of heart rate before and after intravenous injection of opioid analgesics |
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Inclusion Criteria:
Exclusion Criteria:
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120 Chinese female patients receiving elective surgery under general anesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Xianwei, MD | Huazhong University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sufentanil Group | Grouped by intravenous injection of sufentanil at the time of anesthesia induction |
| FG001 | Fentanyl Group | Grouped by intravenous injection of fentanyl at the time of anesthesia induction |
| FG002 | Saline Group | Grouped by intravenous injection of saline before the time of anesthesia induction |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sufentanil Group | Grouped by intravenous injection of sufentanil at the time of anesthesia induction |
| BG001 | Fentanyl Group | Grouped by intravenous injection of fentanyl at the time of anesthesia induction |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Pressure Pain Threshold | According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics | Posted | Mean | Standard Deviation | kg/cm2 | 10 minutes after the procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sufentanil Group | Grouped by intravenous injection of sufentanil at the time of anesthesia induction |
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Because 3 patients couldn't maintain the SPO2 at 90% and 1 patient was at deep sedation, 4 subject patients were not analysed in the final results. These patients were performed as a routine intravenous anesthetic induction.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xianwei Zhang | Huazhong University of Science&Technology | 027 83662853 | ourpain@163.com |
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| 10 minutes after the procedure |
| Mean Respiratory Frequency | According to the measurement of respiratory frequency after intravenous injection of opioid analgesics | 10 minutes after the procedure |
| BG002 | Saline Group | Grouped by intravenous injection of saline before the time of anesthesia induction |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Grouped by intravenous injection of saline before the time of anesthesia induction
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| Primary | Mean Value of Narco-trend Index | According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state. | Posted | Mean | Standard Deviation | units on a scale | 10 minutes after the procedure |
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| Secondary | Mean Arterial Pressure | According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics | Posted | Mean | Standard Deviation | mmHg | 10 minutes after the procedure |
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| Secondary | Mean Heart Rate | According to the measurement of heart rate before and after intravenous injection of opioid analgesics | Posted | Mean | Standard Deviation | beats per minute | 10 minutes after the procedure |
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| Secondary | Mean Respiratory Frequency | According to the measurement of respiratory frequency after intravenous injection of opioid analgesics | Posted | Mean | Standard Deviation | breaths per minute | 10 minutes after the procedure |
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| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Fentanyl Group | Grouped by intravenous injection of fentanyl at the time of anesthesia induction | 0 | 38 | 0 | 38 |
| EG002 | Saline Group | Grouped by intravenous injection of saline before the time of anesthesia induction | 0 | 40 | 0 | 40 |
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