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
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Elective Laparoscopic Surgery
Intervention: 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 (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Yue Kang, MD, Study Director, Affiliation: Abbott
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Time to Loss of ConsciousnessTime to Eye Opening Time to Extubation Time to Orientation
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Site Reference ID/Investigator# 41983, Beijing 100730, China
Site Reference ID/Investigator# 41932, Chengdu, China
Site Reference ID/Investigator# 41985, Guangzhou City 510080, China
Site Reference ID/Investigator# 41984, Shanghai 200032, China
Additional Information
Starting date: November 2010
Last updated: May 31, 2012
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