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

Elective Laparoscopic Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191476
• Other study ID #: R12-564
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2010
• Last updated: May 31, 2012
• Start date: November 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elective Laparoscopic Surgery

Intervention

Drug:
• Sevoflurane Inhalational Induction and Maintenance
Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance.
• Propofol Target Controlled Infusion for Induction and Maintenance
Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction and propofol 3 to 6 ug/mL was administered with TCI for maintenance.
• Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
Propofol was administered as a bolus IV dose of 1.5 mg/kg for induction at a rate of 40 mg/10 seconds. During maintenance, a sevoflurane concentration of 0.8-1.5 minimal alveolar concentration (MAC) was administered at a rate of 1 L/min fresh gas flow.

Locations

Country	Name	City	State
China	Site Reference ID/Investigator# 41983	Beijing
China	Site Reference ID/Investigator# 41932	Chengdu
China	Site Reference ID/Investigator# 41985	Guangzhou City
China	Site Reference ID/Investigator# 41984	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Rundo International Pharmaceutical Research & Development Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane]; [Cost of TIVA = unit price of propofol X total volume of propofol in the syringe]; [Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe].; The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused.	Anesthetic Duration between 1 to 3 Hours	No
Secondary	Time to Loss of Consciousness	Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction.	Up to 10 minutes	No
Secondary	Time to Eye Opening	Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred.	Every minute after anesthesia was stopped until the subjects' eyes opened	No
Secondary	Time to Extubation	Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred.	Every minute after anesthesia was stopped until extubation occurred	No
Secondary	Time to Orientation	Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth).	Every minute after anesthesia was stopped until orientation occurred	No