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.

Study Overview

• Status: Completed
• Conditions: Elective Laparoscopic Surgery
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Site Reference ID/Investigator# 41983
  • Chengdu, China
    • Site Reference ID/Investigator# 41932
  • Guangzhou City, China, 510080
    • Site Reference ID/Investigator# 41985
  • Shanghai, China, 200032
    • Site Reference ID/Investigator# 41984

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Sevorane; Sevofrane; Ultane; sevoflurane; ABT-941
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 Names: 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: Sevorane; Sevofrane; Ultane; sevoflurane; ABT-941

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Anesthetic Duration between 1 to 3 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 10 minutes
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.	Every minute after anesthesia was stopped until the subjects' eyes opened
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.	Every minute after anesthesia was stopped until extubation occurred
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).	Every minute after anesthesia was stopped until orientation occurred

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Rundo International Pharmaceutical Research & Development Co.,Ltd.
• Investigators: Study Director: Yue Kang, MD, Abbott

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 27, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Estimate): July 3, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Chinese; Propofol; Sevoflurane; Pharmaceutical; Economics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: R12-564