Status:
COMPLETED
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
Lead Sponsor:
Abbott
Collaborating Sponsors:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Conditions:
Elective Laparoscopic Surgery
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 propofo...
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 mai...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT01191476
Start Date
November 1 2010
End Date
May 1 2011
Last Update
July 3 2012
Active Locations (4)
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1
Site Reference ID/Investigator# 41983
Beijing, China, 100730
2
Site Reference ID/Investigator# 41932
Chengdu, China
3
Site Reference ID/Investigator# 41985
Guangzhou, China, 510080
4
Site Reference ID/Investigator# 41984
Shanghai, China, 200032