Compare Pharmaco-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
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laparoscopy
Intervention: Sevoflurane VIMA (Drug); Propofol TCI (Drug); Sevoflurane (Drug); Propofol (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Abbott Overall contact:
Xi Zhang, MD, Phone: 86 - 21 - 23204221, Email: xi.zhang@abbott.com
Summary
This study is performed to demonstrate that the direct anesthetic costs of a low fresh gas
flow balanced sevoflurane anesthesia for elective laparoscopy are less compared to the
direct anesthetic costs of a target-controlled infusion anesthesia based on propofol.
Clinical Details
Official title: Prospective, Randomized, Open-label Multicenter Study Comparing the Pharmaco-economics and Efficacy 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 VIMA, TIVA or intravenous induction and inhalation maintenance with sevoflurane and propofol in laparoscopic operations in China.
Secondary outcome: Time to loss of consciousnessTime to eye opening Time to extubation Time to orientation
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Men or women, aged from 18 to 65, with physical status ASA(American Society of
Anesthesiologists) I or II
2. In patients with body mass index (weight/height^2) of from 16 to 30 kg/m^2
3. Elective surgery of laparoscopic surgery requiring general anesthesia managed with
endotracheal intubation
4. The planned time of anesthesia will be greater than or equal to 60 min, but less than
180 minutes in length
Exclusion Criteria:
1. Patients known to be hypersensitive or unusual response to any halogenated
anesthetics.
2. Significant cardiovascular, pulmonary, hepatic, renal, central nervous system or
muscular disease.
3. Patients having pre-operative cognitive dysfunction or disabling neuropsychiatric
disorders.
4. Emergency surgery or surgery requiring additional regional anesthetic techniques.
5. Intracranial surgery, cardio-surgery or thoracic surgery.
6. Subjects unable to cooperate with the anesthetist prior to administration of the
anesthetic agent
7. Patients with personal or familial history or suspected susceptibility to malignant
hyperthermia.
8. Women either pregnant or breast feeding.
Locations and Contacts
Xi Zhang, MD, Phone: 86 - 21 - 23204221, Email: xi.zhang@abbott.com
Zhongshan Hospital, Fudan University, Shanghai 200032, China
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Wangfujing, Beijing 100730, China
The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510080, China
West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
Additional Information
For ULTANE prescribing information, see link
Starting date: August 2010
Last updated: August 27, 2010
|
