Trial · NCT01191476
Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia
NCT01191476, Phase 4, Completed, Abbott; results first posted 2012-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia. Trials, record NCT01191476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191476
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia
- NCT number
- NCT01191476
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 336 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Elective Laparoscopic Surgery
- Interventions
Sevoflurane Inhalational Induction and Maintenance, Propofol Target Controlled Infusion for Induction and Maintenance, Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
- First posted
- 2010-08-30
- Last updated
- 2012-07-03
- Results first posted
- 2012-07-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Anesthetic Duration between 1 to 3 Hours | The full analysis set was used for the determination of cost of anesthesia. | Yuan | MEAN |
| SECONDARY | Time to Loss of Consciousness | Up to 10 minutes | seconds | MEAN | |
| SECONDARY | Time to Eye Opening | Every minute after anesthesia was stopped until the subjects' eyes opened | Minutes | MEAN | |
| SECONDARY | Time to Extubation | Every minute after anesthesia was stopped until extubation occurred | Measurement | Minutes | MEAN |
| SECONDARY | Time to Orientation | Every minute after anesthesia was stopped until orientation occurred | Minutes | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Sevoflurane | 380.78 | Standard Deviation 108.53 | Yuan | |
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 | Propofol | 548.52 | Standard Deviation 195.14 | Yuan | |
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 | Propofol Induction Sevoflurane Maintenance | 269.40 | Standard Deviation 74.04 | Yuan | |
| Time to Loss of Consciousness | Sevoflurane | 48.54 | Standard Deviation 22.77 | seconds | |
| Time to Loss of Consciousness | Propofol | 100.32 | Standard Deviation 55.15 | seconds | |
| Time to Loss of Consciousness | Propofol Induction Sevoflurane Maintenance | 68.76 | Standard Deviation 34.96 | seconds | |
| Time to Eye Opening | Sevoflurane | 8.38 | Standard Deviation 3.66 | Minutes | |
| Time to Eye Opening | Propofol | 9.79 | Standard Deviation 6.92 | Minutes | |
| Time to Eye Opening | Propofol Induction Sevoflurane Maintenance | 8.69 | Standard Deviation 3.50 | Minutes | |
| Time to Extubation | Sevoflurane | 9.69 | Standard Deviation 3.84 | Minutes |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sevoflurane | 112 | |
| Overall Study | STARTED | Propofol | 111 | |
| Overall Study | STARTED | Propofol Induction Sevoflurane Maintenance | 111 | |
| Overall Study | COMPLETED | Sevoflurane | 109 | |
| Overall Study | COMPLETED | Propofol | 107 | |
| Overall Study | COMPLETED | Propofol Induction Sevoflurane Maintenance | 111 | |
| Overall Study | NOT COMPLETED | Sevoflurane | 3 | |
| Overall Study | NOT COMPLETED | Propofol | 4 | |
| Overall Study | NOT COMPLETED | Propofol Induction Sevoflurane Maintenance | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | bradycardia | Cardiac disorders | Sevoflurane | 3 | 112 | |
| other | bradycardia | Cardiac disorders | Propofol | 0 | 111 | |
| other | bradycardia | Cardiac disorders | Propofol Induction Sevoflurane Maintenance | 1 | 111 | |
| other | diastolic blood pressure decreased | Investigations | Sevoflurane | 0 | 112 | |
| other | diastolic blood pressure decreased | Investigations | Propofol | 0 | 111 | |
| other | diastolic blood pressure decreased | Investigations | Propofol Induction Sevoflurane Maintenance | 1 | 111 | |
| other | hypotension | Vascular disorders | Sevoflurane | 3 | 112 | |
| other | hypotension | Vascular disorders | Propofol | 2 | 111 | |
| other | hypotension | Vascular disorders | Propofol Induction Sevoflurane Maintenance | 2 | 111 | |
| other | Movement Disorder | Nervous system disorders | Sevoflurane | 0 | 112 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sevoflurane | ||
| Total, all-cause mortality | Propofol | ||
| Total, all-cause mortality | Propofol Induction Sevoflurane Maintenance | ||
| Total, other adverse events | Sevoflurane | 5 | 112 |
| Total, other adverse events | Propofol | 4 | 111 |
| Total, other adverse events | Propofol Induction Sevoflurane Maintenance | 5 | 111 |
| Total, serious adverse events | Sevoflurane | 0 | 112 |
| Total, serious adverse events | Propofol | 0 | 111 |
| Total, serious adverse events | Propofol Induction Sevoflurane Maintenance | 0 | 111 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01191476
GET https://conductscience.org/api/trials/v1/NCT01191476/registered