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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

This study has been completed.
Sponsor:
Collaborator:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01191476
First received: August 27, 2010
Last updated: May 31, 2012
Last verified: May 2012

August 27, 2010
May 31, 2012
November 2010
May 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]

[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.

Cost of VIMA, TIVA or intravenous induction and inhalation maintenance with sevoflurane and propofol in laparoscopic operations in China. [ Time Frame: Within 3 hours ] [ Designated as safety issue: No ]
VIMA: the cost of sevoflurane is the product of the unit price of sevoflurane and the used volume of sevoflurane.CVIMA = Usevo • Vsevo TIVA: the cost of propofol is the product of the unit price of propofol and the used "syringe" of propofol.CTIVA = Uprop • Vprop Intravenous induction and inhalation maintenance: the cost of anesthetics is the sum of the cost of propofol in induction and the cost of sevoflurane in maintenance.CCOMBINED = Uprop • Vprop + Usevo • Vsevo.Usevo and Uprop are the unit price of sevoflurane and propofol.Vsevo and Vprop are the used volume of sevoflurane and propofol
Complete list of historical versions of study NCT01191476 on ClinicalTrials.gov Archive Site
  • Time to Loss of Consciousness [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every minute after anesthesia was stopped until the subjects' eyes opened ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every minute after anesthesia was stopped until extubation occurred ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every minute after anesthesia was stopped until orientation occurred ] [ Designated as safety issue: No ]
    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 to loss of consciousness [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    Measured by the time from the commence of investigate drug administration to loss of consciousness (response to command).
  • Time to eye opening [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    Measured by the time from cessation of sevoflurane or propofol administration to opening of eyes. Approximately 5 minutes after anesthesia cessation, the investigators lightly tap on the patient's forehead or shoulder and ask the patient to open their eyes. This process will be repeated about every minute until the patient follows the command.
  • Time to extubation [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]

    The time from cessation of sevoflurane or propofol administration to tracheal extubation, extubation criteria are:

    • TOF > 0.9
    • Tidal Volume > 5ml/kg
    • Minute Ventilation > 3 L
    • Respiratory Rate > 10 bpm
    • ETCO2 < 45 mmHg
    • Eye-opening
  • Time to orientation [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    time from cessation of sevoflurane or propofol administration to be able to state name and date of birth
Not Provided
Not Provided
 
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 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Elective Laparoscopic Surgery
  • Drug: Sevoflurane 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.
    Other Names:
    • ABT-941
    • sevoflurane
    • Ultane
    • Sevorane
    • Sevofrane
  • Drug: Propofol 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.
    Other Name: Propofol
  • Drug: Propofol 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.
    Other Names:
    • ABT-941
    • sevoflurane
    • Ultane
    • Sevorane
    • Sevofrane
  • Active Comparator: Sevoflurane
    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).
    Intervention: Drug: Sevoflurane Inhalational Induction and Maintenance
  • Active Comparator: Propofol
    Subjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia.
    Intervention: Drug: Propofol Target Controlled Infusion for Induction and Maintenance
  • Active Comparator: Propofol Induction and Sevoflurane Maintenance
    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.
    Intervention: Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01191476
R12-564
No
Abbott
Abbott
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Study Director: Yue Kang, MD Abbott
Abbott
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP