The Effect of BIS Monitorization to Intraoperative Anesthetic Consumption During Coronary Artery Surgery
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
213 patients undergoing elective on-pump coronary artery bypass grafting (CABG) were enrolled into this prospective-clinical trial.After hundred and sixty three patients were excluded due to various reasons, 50 patients were randomized to BIS (bispectral index) and MAC (minimum alveolar concentration) groups. In BIS group (Group B, n=25), desflurane was titrated within 40 to 60 BIS values and in MAC group (Group M, n=25) within 0.7 to 1.3 MAC. Primary end point of the study was to investigate the difference of desflurane consumption between groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedAugust 13, 2015
August 1, 2015
9 months
August 5, 2015
August 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total and hourly amounts of desflurane consumption
A more than 20 % reduction in total and hourly amounts of desflurane consumption
up to 12 hours
Secondary Outcomes (3)
Time to extubation
up to 2 days
Mortality
28 days
Morbidity
28 days
Study Arms (2)
Bispectral index
EXPERIMENTALThe group that desflurane titrated according to bispectral index monitoring
Minimum alveolar concentration
OTHERThe group that desflurane consumption titrated according to minimum alveolar concentration monitoring
Interventions
volatile agent for maintenance of anesthesia
Eligibility Criteria
You may qualify if:
- Undergoing elective on-pump CABG surgery
- Having an American Society of Anesthesiologists' (ASA) physical status of 3 to 4
You may not qualify if:
- A contraindication to the administration of the study drugs
- History of psychiatric and/or neurological disorder
- A left ventricular ejection fraction (EF) \< 30%
- A body mass index (BMI) \> 30 kg/ m2
- Urgent surgery
- Myocard infarction within 48 hours
- Preoperative need for inotropic/vasodilator agents
- History of heart surgery
- Preoperative or intraoperative need for intraaortic balloon pump
- Left ventricular aneurysms
- Severe pulmonary, renal or hepatic dysfunction
- Presence of excessive alcohol intake or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 13, 2015
Study Start
January 1, 2014
Primary Completion
October 1, 2014
Study Completion
November 1, 2014
Last Updated
August 13, 2015
Record last verified: 2015-08