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
1 other identifier
interventional
336
1 country
4
Brief 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 anesthesic use between 1 and 3 hour duration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2010
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
July 3, 2012
CompletedJuly 3, 2012
May 1, 2012
6 months
August 27, 2010
May 31, 2012
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Anesthetic Duration between 1 to 3 Hours
Secondary Outcomes (4)
Time to Loss of Consciousness
Up to 10 minutes
Time to Eye Opening
Every minute after anesthesia was stopped until the subjects' eyes opened
Time to Extubation
Every minute after anesthesia was stopped until extubation occurred
Time to Orientation
Every minute after anesthesia was stopped until orientation occurred
Study Arms (3)
Sevoflurane
ACTIVE 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).
Propofol
ACTIVE COMPARATORSubjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia.
Propofol Induction and Sevoflurane Maintenance
ACTIVE 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.
Interventions
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 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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Site Reference ID/Investigator# 41983
Beijing, 100730, China
Site Reference ID/Investigator# 41932
Chengdu, China
Site Reference ID/Investigator# 41985
Guangzhou, 510080, China
Site Reference ID/Investigator# 41984
Shanghai, 200032, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Yue Kang, MD
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2010
First Posted
August 30, 2010
Study Start
November 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
July 3, 2012
Results First Posted
July 3, 2012
Record last verified: 2012-05