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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 Consciousness

Time 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

Page last updated: August 23, 2015

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