Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG
1 other identifier
interventional
76
1 country
1
Brief Summary
In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFebruary 4, 2014
February 1, 2014
1 year
October 10, 2012
February 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACie
Minimal Alveolar Concentration of sevoflurane and NO inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
30min
Study Arms (2)
Group 1 Sevoflurane+Nitrous oxide
ACTIVE COMPARATORGroup 2 Sevoflurane
ACTIVE COMPARATORInterventions
60% nitrous oxide +40% oxygen+ Sevoflurane
Eligibility Criteria
You may qualify if:
- between 45 to 64 years old
- ASA physical status class 1 or 2
- elective abdominal surgery
- Informed Consent
You may not qualify if:
- history of neurological disease
- received central nervous system-active drugs
- cardiac ejection fraction less than 40%
- history of difficult intubation or anticipated difficult intubation
- daily alcohol consumption
- obesity, defined as a body-mass index of more than 30
- without informed consent
- others judged inappropriate as subjects for the study by the Study Chair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yuke Tian, MD.
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 10, 2012
First Posted
October 12, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
February 4, 2014
Record last verified: 2014-02