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| Name | Class |
|---|---|
| Rundo International Pharmaceutical Research & Development Co.,Ltd. | INDUSTRY |
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This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.
Three hundred thirty-six subjects were enrolled in this study. Two subjects, one treated with propofol for induction and maintenance and one treated with propofol for induction and sevoflurane for maintenance are not included in the study participation since no information was available for these two subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane | Active Comparator | Subjects received sevoflurane, a inhalational (volatile) anesthetic, which was administered for induction and maintenance of general anesthesia. Inhalational induction was induced via vital capacity induction at 8% and maintained at 0.8-1.5 minimum alveolar concentration (MAC). |
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| Propofol | Active Comparator | Subjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia. |
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| Propofol Induction and Sevoflurane Maintenance | Active Comparator | Subjects received a bolus dose of propofol of 1.5 mg/kg administered for IV induction followed by sevoflurane at 0.8-1.5 MAC for maintenance anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane Inhalational Induction and Maintenance | Drug | Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane | [Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane]; [Cost of TIVA = unit price of propofol X total volume of propofol in the syringe]; [Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe]. The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused. | Anesthetic Duration between 1 to 3 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Loss of Consciousness | Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yue Kang, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 41983 | Beijing | 100730 | China | |||
| Site Reference ID/Investigator# 41932 |
The study was a prospective, randomized (1:1:1), open-label, multi-center study comparing the cost of inhalational anesthesia with sevoflurane to intravenous (IV) anesthesia with propofol, or propofol for induction and sevoflurane for maintenance of anesthesia. The full analysis set was used for determination of all primary and secondary endpoints.
Subjects between the ages of 18 and 65 were recruited from 4 hospitals in 4 cities in China. They were required to have elective laparoscopic, in-patient surgery with a predicted anesthetic duration between 1 to 3 hours. Subjects with ASA physical status I or II were enrolled and were to have had the ability to provide informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sevoflurane | Inhalational induction and maintenance anesthesia with sevoflurane. |
| FG001 | Propofol | Target controlled infusion anesthesia with propofol for induction and maintenance. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Propofol Target Controlled Infusion for Induction and Maintenance | Drug | Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction and propofol 3 to 6 ug/mL was administered with TCI for maintenance. |
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| Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance | Drug | Propofol was administered as a bolus IV dose of 1.5 mg/kg for induction at a rate of 40 mg/10 seconds. During maintenance, a sevoflurane concentration of 0.8-1.5 minimal alveolar concentration (MAC) was administered at a rate of 1 L/min fresh gas flow. |
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| Up to 10 minutes |
| Time to Eye Opening | Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred. | Every minute after anesthesia was stopped until the subjects' eyes opened |
| Time to Extubation | Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred. | Every minute after anesthesia was stopped until extubation occurred |
| Time to Orientation | Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth). | Every minute after anesthesia was stopped until orientation occurred |
| Chengdu |
| China |
| Site Reference ID/Investigator# 41985 | Guangzhou | 510080 | China |
| Site Reference ID/Investigator# 41984 | Shanghai | 200032 | China |
| FG002 | Propofol Induction Sevoflurane Maintenance | Propofol induction and sevoflurane maintenance anesthesia. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sevoflurane | Inhalational induction and maintenance anesthesia with sevoflurane. |
| BG001 | Propofol | Target controlled infusion anesthesia with propofol for induction and maintenance. |
| BG002 | Propofol Induction Sevoflurane Maintenance | Propofol induction and sevoflurane maintenance anesthesia. |
| BG003 | Total | Total of all reporting groups |
| 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 | 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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| 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 | Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane | [Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane]; [Cost of TIVA = unit price of propofol X total volume of propofol in the syringe]; [Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe]. The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused. | The full analysis set was used for the determination of cost of anesthesia. | Posted | Mean | Standard Deviation | Yuan | Anesthetic Duration between 1 to 3 Hours |
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| Secondary | Time to Loss of Consciousness | Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction. | Posted | Mean | Standard Deviation | seconds | Up to 10 minutes |
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| Secondary | Time to Eye Opening | Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred. | Posted | Mean | Standard Deviation | Minutes | Every minute after anesthesia was stopped until the subjects' eyes opened |
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| Secondary | Time to Extubation | Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred. | Measurement | Posted | Mean | Standard Deviation | Minutes | Every minute after anesthesia was stopped until extubation occurred |
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| Secondary | Time to Orientation | Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth). | Posted | Mean | Standard Deviation | Minutes | Every minute after anesthesia was stopped until orientation occurred |
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All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.
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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 | Sevoflurane | Inhalational induction and maintenance anesthesia with sevoflurane. | 0 | 112 | 5 | 112 | ||
| EG001 | Propofol | Target controlled infusion anesthesia with propofol for induction and maintenance. | 0 | 111 | 4 | 111 | ||
| EG002 | Propofol Induction Sevoflurane Maintenance | Propofol induction and sevoflurane maintenance anesthesia. | 0 | 111 | 5 | 111 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| diastolic blood pressure decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Movement Disorder | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D008283 | Maintenance |
| D000077149 | Sevoflurane |
| D020360 | Neoadjuvant Therapy |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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