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
  Purpose

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.


Condition Intervention Phase
Elective Laparoscopic Surgery
Drug: Sevoflurane Inhalational Induction and Maintenance
Drug: Propofol Target Controlled Infusion for Induction and Maintenance
Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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).


Enrollment: 336
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
Active Comparator: Propofol
Subjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191476

Locations
China
Site Reference ID/Investigator# 41983
Beijing, China, 100730
Site Reference ID/Investigator# 41932
Chengdu, China
Site Reference ID/Investigator# 41985
Guangzhou City, China, 510080
Site Reference ID/Investigator# 41984
Shanghai, China, 200032
Sponsors and Collaborators
Abbott
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Investigators
Study Director: Yue Kang, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01191476     History of Changes
Other Study ID Numbers: R12-564
Study First Received: August 27, 2010
Results First Received: May 31, 2012
Last Updated: May 31, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Abbott:
Sevoflurane
Propofol
Economics
Pharmaceutical
Chinese

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on September 18, 2014