Clinical trial NCT01191476: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elective Laparoscopic Surgery
Keywords: Sevoflurane
Propofol
Economics
Pharmaceutical
Chinese
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Rundo International Pharmaceutical Research & Development Co.,Ltd.
First posted: 2010-08-30
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
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
timeFrame: Anesthetic Duration between 1 to 3 Hours
Secondary outcomes:
measure: Time to Loss of Consciousness
timeFrame: Up to 10 minutes
measure: Time to Eye Opening
timeFrame: Every minute after anesthesia was stopped until the subjects' eyes opened
measure: Time to Extubation
timeFrame: Every minute after anesthesia was stopped until extubation occurred
measure: Time to Orientation
timeFrame: Every minute after anesthesia was stopped until orientation occurred
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site Reference ID/Investigator# 41983
city: Chengdu
country: China
facility: Site Reference ID/Investigator# 41932
city: Guangzhou City
country: China
facility: Site Reference ID/Investigator# 41985
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 41984
Study officials:
affiliation: Abbott
name: Yue Kang, MD
role: STUDY_DIRECTOR
References: