Elective Laparoscopic Surgery
Conditions
Keywords
Sevoflurane, Propofol, Economics, Pharmaceutical, Chinese
Brief summary
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.
Detailed description
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.
Interventions
DRUGPropofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
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.
DRUGSevoflurane Inhalational Induction and Maintenance
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.
DRUGPropofol Target Controlled Infusion for Induction and Maintenance
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.
Sponsors
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women, aged from 18 to 65 2. ASA (American Society of Anesthesiologists) physical status (a requirement of the subject's physical status): I or II 3. Body mass index (weight/height\^2) from 16 to 30 kg/m\^2 4. Elective laparoscopic surgery requiring general anesthesia managed with endotracheal intubation 5. Duration of anesthesia use will be greater than or equal to 1 hour, but less than 3 hours in length.
Exclusion criteria
1. Hypersensitivity or unusual response to any halogenated anesthetics. 2. History of significant cardiovascular, pulmonary, hepatic, renal, central nervous system or muscular disease. 3. Pre-operative cognitive dysfunction or disabling neuropsychiatric disorders. 4. Need for emergency surgery or surgery requiring additional regional anesthetic techniques. 5. Need for intracranial surgery, cardio-surgery or thoracic surgery. 6. Subjects inability to cooperate with the anesthetist before administration of the anesthetic agent. 7. Personal or familial history of malignant hyperthermia. 8. Females who are either pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Anesthetic Duration between 1 to 3 Hours | \[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane\]; \[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe\]; \[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe\]. The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Loss of Consciousness | Up to 10 minutes | 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. |
| Time to Eye Opening | Every minute after anesthesia was stopped until the subjects' eyes opened | 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. |
| Time to Extubation | Every minute after anesthesia was stopped until extubation occurred | 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. |
| Time to Orientation | Every minute after anesthesia was stopped until orientation occurred | 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). |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Sevoflurane Inhalational induction and maintenance anesthesia with sevoflurane. | 112 |
| Propofol Target controlled infusion anesthesia with propofol for induction and maintenance. | 111 |
| Propofol Induction Sevoflurane Maintenance Propofol induction and sevoflurane maintenance anesthesia. | 111 |
| Total | 334 |
Baseline characteristics
| Characteristic | Propofol | Propofol Induction Sevoflurane Maintenance | Sevoflurane | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 111 Participants | 111 Participants | 112 Participants | 334 Participants |
| Age Continuous | 43.26 years STANDARD_DEVIATION 12.05 | 42.51 years STANDARD_DEVIATION 11.81 | 42.29 years STANDARD_DEVIATION 12.15 | 42.71 years STANDARD_DEVIATION 11.96 |
| Region of Enrollment China | 111 participants | 111 participants | 112 participants | 334 participants |
| Sex: Female, Male Female | 92 Participants | 87 Participants | 92 Participants | 271 Participants |
| Sex: Female, Male Male | 19 Participants | 24 Participants | 20 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 112 | 4 / 111 | 5 / 111 |
| serious Total, serious adverse events | 0 / 112 | 0 / 111 | 0 / 111 |
Outcome results
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.
Time frame: Anesthetic Duration between 1 to 3 Hours
Population: The full analysis set was used for the determination of cost of anesthesia.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sevoflurane | 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 | 380.78 Yuan | Standard Deviation 108.53 |
| Propofol | 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 | 548.52 Yuan | Standard Deviation 195.14 |
| Propofol Induction Sevoflurane Maintenance | 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 | 269.40 Yuan | Standard Deviation 74.04 |
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.
Time frame: Every minute after anesthesia was stopped until extubation occurred
Population: Measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sevoflurane | Time to Extubation | 9.69 Minutes | Standard Deviation 3.84 |
| Propofol | Time to Extubation | 11.32 Minutes | Standard Deviation 6.91 |
| Propofol Induction Sevoflurane Maintenance | Time to Extubation | 9.79 Minutes | Standard Deviation 3.52 |
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.
Time frame: Every minute after anesthesia was stopped until the subjects' eyes opened
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sevoflurane | Time to Eye Opening | 8.38 Minutes | Standard Deviation 3.66 |
| Propofol | Time to Eye Opening | 9.79 Minutes | Standard Deviation 6.92 |
| Propofol Induction Sevoflurane Maintenance | Time to Eye Opening | 8.69 Minutes | Standard Deviation 3.5 |
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.
Time frame: Up to 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sevoflurane | Time to Loss of Consciousness | 48.54 seconds | Standard Deviation 22.77 |
| Propofol | Time to Loss of Consciousness | 100.32 seconds | Standard Deviation 55.15 |
| Propofol Induction Sevoflurane Maintenance | Time to Loss of Consciousness | 68.76 seconds | Standard Deviation 34.96 |
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).
Time frame: Every minute after anesthesia was stopped until orientation occurred
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sevoflurane | Time to Orientation | 13.97 Minutes | Standard Deviation 6.73 |
| Propofol | Time to Orientation | 17.64 Minutes | Standard Deviation 12.45 |
| Propofol Induction Sevoflurane Maintenance | Time to Orientation | 14.95 Minutes | Standard Deviation 6.39 |