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Elective Laparoscopic SurgeryPhase 4NCT01191476

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

A Phase 4 study testing Sevoflurane Inhalational Induction and Maintenance in people with Elective Laparoscopic Surgery, run by Abbott at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Elective Laparoscopic Surgery
What is being tested?
Sevoflurane Inhalational Induction and Maintenance
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
4 sitesChina
Study dates
Nov 2010to May 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women, aged from 18 to 65
  • ASA (American Society of Anesthesiologists) physical status (a requirement of the subject's physical status): I or II
  • Body mass index (weight/height^2) from 16 to 30 kg/m^2
  • Elective laparoscopic surgery requiring general anesthesia managed with endotracheal intubation
  • Duration of anesthesia use will be greater than or equal to 1 hour, but less than 3 hours in length.

Who cannot join

  • Hypersensitivity or unusual response to any halogenated anesthetics.
  • History of significant cardiovascular, pulmonary, hepatic, renal, central nervous system or muscular disease.
  • Pre-operative cognitive dysfunction or disabling neuropsychiatric disorders.
  • Need for emergency surgery or surgery requiring additional regional anesthetic techniques.
  • Need for intracranial surgery, cardio-surgery or thoracic surgery.
  • Subjects inability to cooperate with the anesthetist before administration of the anesthetic agent.
  • Personal or familial history of malignant hyperthermia.
  • Females who are either pregnant or breast feeding.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Site Reference ID/Investigator# 41983

    Beijing, 100730

  • Site Reference ID/Investigator# 41932

    Chengdu

  • Site Reference ID/Investigator# 41985

    Guangzhou, 510080

  • Site Reference ID/Investigator# 41984

    Shanghai, 200032

Other trials in China

About this study

Official title: A Prospective, Randomized, Open-label Multicenter Study Comparing the Pharmaceutical Economics and Effectiveness of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia in Laparoscopic Surgeries in China

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.

Read the 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.

Being tested
Sevoflurane Inhalational Induction and Maintenance, Propofol Target Controlled Infusion for Induction and Maintenance, Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
Keywords
Sevoflurane, Propofol, Economics, Pharmaceutical, Chinese

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sevoflurane Inhalational Induction and MaintenanceDrug

    Also called ABT-941, sevoflurane, Ultane, Sevorane

    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.

  • Propofol Target Controlled Infusion for Induction and MaintenanceDrug

    Also called Propofol

    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.

  • Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for MaintenanceDrug

    Also called ABT-941, sevoflurane, Ultane, Sevorane

    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.

Study groups in NCT01191476
Study groupRoleWhat they receive
SevofluraneActive comparatorSubjects 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).
Receives: Drug: Sevoflurane Inhalational Induction and Maintenance
PropofolActive comparatorSubjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia.
Receives: Drug: Propofol Target Controlled Infusion for Induction and Maintenance
Propofol Induction and Sevoflurane MaintenanceActive comparatorSubjects 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.
Receives: Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Anesthetic Duration between 1 to 3 Hours

Secondary outcomes (4)

  1. 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.

    Measured: Up to 10 minutes

  2. 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.

    Measured: Every minute after anesthesia was stopped until the subjects' eyes opened

  3. 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.

    Measured: Every minute after anesthesia was stopped until extubation occurred

  4. 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).

    Measured: Every minute after anesthesia was stopped until orientation occurred

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01191476
Sponsor's protocol ID
R12-564
Status last verified
May 2012
First submitted
27 Aug 2010
Last updated
3 Jul 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sevoflurane Inhalational Induction and Maintenance in people with Elective Laparoscopic Surgery, run by Abbott at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Anesthetic Duration between 1 to 3 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01191476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.

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