The Effect of BIS Monitorization to Intraoperative Anesthetic Consumption During Coronary Artery Surgery
Primary Purpose
Unconscious State
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BIS
Desflurane
Sponsored by
About this trial
This is an interventional health services research trial for Unconscious State focused on measuring desflurane, BIS, coronary artery bypass grafting surgery
Eligibility Criteria
Inclusion Criteria:
- Undergoing elective on-pump CABG surgery
- Having an American Society of Anesthesiologists' (ASA) physical status of 3 to 4
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Bispectral index
Minimum alveolar concentration
Arm Description
The group that desflurane titrated according to bispectral index monitoring
The group that desflurane consumption titrated according to minimum alveolar concentration monitoring
Outcomes
Primary Outcome Measures
Total and hourly amounts of desflurane consumption
A more than 20 % reduction in total and hourly amounts of desflurane consumption
Secondary Outcome Measures
Time to extubation
participants was followed for the duration of extubation
Mortality
participants was followed for 28 days after surgery
Morbidity
participants was followed for 28 days after surgery for any systemic complications
Full Information
NCT ID
NCT02520947
First Posted
August 5, 2015
Last Updated
August 12, 2015
Sponsor
Baskent University Ankara Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02520947
Brief Title
The Effect of BIS Monitorization to Intraoperative Anesthetic Consumption During Coronary Artery Surgery
Official Title
The Effect of BIS Monitorization to Intraoperative Anesthetic and Analgesic Consumption During Coronary Artery Grafting Surgery and Postoperative Mortality and Morbidity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University Ankara Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This study was approved by Baskent University Institutional Review Board and Ethics Committee (Project No: KA13/294) and supported by Baskent University Research Fund. The study was conducted in a single university hospital (Başkent University Hospital, Ankara, Turkey). Between January 2014 and October 2014, 213 patients undergoing CABG surgery were assessed for eligibility. 163 patients were excluded because of not meeting inclusion criteria. 50 patients were enrolled into this prospective-clinical trial. All patients were informed of the nature of the study and gave their written consent during preoperative visit performed by the investigators.Diazepam 0.1 mg/kg (Diazem®) and famotidine HCI 40 mg (Famodin®) were given by the oral route to all patients, the day before surgery at 11 pm and midazolam 0.1 mg/kg (Dormicum®) was given to all patients by oral route 30 min before starting anesthesia. After routine 5 lead electrocardiography, pulse oximeter monitoring and peripheric venous and arterial cannulations, endotracheal intubation was performed. BIS monitoring (BIS Quatro Sensor, Aspect Medical Systems, Inc, Norwood, MA, USA) was applied to BIS group in accordance with the manufacturer's instructions. Anesthesia was induced with propofol 1-2 mg/kg and fentanyl 5-7 mcg/kg by intravenous route, based on the patient's physical status. Muscle relaxation was achieved using iv rocuronium 0.6 mg/kg. Desflurane was administered through a calibrated vaporizer (D-Vapor, Drager Medical AG&Co. KG, Lübeck, Germany) in both groups.
In BIS group (Grup B, n=25) desflurane was titrated to maintain a BIS value of 40 to 60. Anesthesia was maintained with remifentanil 0.1-0.4 mcg/kg/min, and desflurane as a volatile agent. In MAC group (Grup M, n=25) desflurane was titrated within 0.7 to 1.3 MAC. During maintenance, all patients were assessed for hypotension (systolic artery pressure (SAP) < 20% from baseline), bradycardia (heart rate (HR) < 45 bpm) or signs of inadequate anesthesia. Inadequate anesthesia was defined as hypertension (SAP >20% from baseline), tachycardia (HR > 100 bpm) or patient movement, eye opening, swallowing, grimacing, lacrimation or sweating. In MAC group, if anesthesia was inadequate, the desflurane concentration was increased in steps of 0.5 vol % as necessary. In BIS group desflurane was titrated for BIS values between 40 and 60. If this was judged insufficient, the infusion rate of remifentanil was increased by 0.05 g/kg/min. Hemodynamic parameters were maintained within 20% of the basal values with dopamine and nitroglycerin, as required. Dopamine was administered 2-20 mcg/kg/min by central venous route. Calcium and noradrenaline were used as iv boluses if needed. All patients were given fluid infusions to maintain central venous pressure between 10-15 mmHg. Hypotension was initially treated with 100-250 mL iv fluid boluses; desflurane concentration was then reduced in steps of 0.5 vol % and finally, an iv vasopressor (dopamine, adrenaline, dobutamine) was given at a dose chosen by the practitioners. Bradycardia was treated with 0.5 mg atropine. Practitioners were reminded of this protocol via a visual protocol in the room. Morphine 0.1 mg/kg was given all of the patients for pain control. The amount of desflurane administered from the start of the anesthesia to the end of surgical procedure was calculated in two groups. The amount of desflurane administered during the procedure was calculated by using the formula below:
Consumption of anesthetic agent in ml/hr = 3 X set concentration % X fresh gas flow L/min.Patient characteristics and surgical variables such as intraoperative blood loss, anesthesia and surgery durations, BIS (bispectral index) and MAC (minimum alveolar concentration) values, intraoperative hemodynamic parameters and drug requirements of patients, amounts of fluid and blood administered, CVP, urine output, features of the surgery were documented by research staff. All patients were transferred to the ICU. Applying an a priory power analysis, 24 patients at least had to be enrolled in each group to detect a reduction of 20% at least in desflurane consumption with a risk of a of 0.05 and a statistical power of 0.8. Vanderbilt University power and sample size calculation program had been used for power analysis.
Data are presented as medians (interquantile ranges), percentages, or number of cases. Continuous data were compared by Mann-Whitney tests. Categorical data were compared with ki-square test. Significance was defined by P values less than 0.05 using a two-tailed test. Data analysis was performed using IBM-SPSS version 20.0 (IBM-SPSS Science Inc., Chicago, IL). Demographic features, intraoperative use of propofol, intraoperative hourly and total amounts of remifentanil, fentanyl, muscle relaxant and morphine, hourly desflurane consumption, hemodynamic parameters, duration of surgery, aortic cross-clamp and cardiopulmonary bypass (CPB) times, defibrillation and pacemaker requirements, maximum positive inotropic and vasodilator drug requirements, amount of intraoperative fluids, blood and blood products used, urine outputs at the end of the surgery and central venous pressure (CVP) values, intraoperative arterial blood gas results were recorded.Durations of intubation, mechanical ventilation, lengths of ICU and hospital stay, 28 days mortality and postoperative complications were also recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unconscious State
Keywords
desflurane, BIS, coronary artery bypass grafting surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bispectral index
Arm Type
Experimental
Arm Description
The group that desflurane titrated according to bispectral index monitoring
Arm Title
Minimum alveolar concentration
Arm Type
Other
Arm Description
The group that desflurane consumption titrated according to minimum alveolar concentration monitoring
Intervention Type
Device
Intervention Name(s)
BIS
Other Intervention Name(s)
processed electroencephalograpy
Intervention Description
Bispectral index monitoring
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
suprane
Intervention Description
volatile agent for maintenance of anesthesia
Primary Outcome Measure Information:
Title
Total and hourly amounts of desflurane consumption
Description
A more than 20 % reduction in total and hourly amounts of desflurane consumption
Time Frame
up to 12 hours
Secondary Outcome Measure Information:
Title
Time to extubation
Description
participants was followed for the duration of extubation
Time Frame
up to 2 days
Title
Mortality
Description
participants was followed for 28 days after surgery
Time Frame
28 days
Title
Morbidity
Description
participants was followed for 28 days after surgery for any systemic complications
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergoing elective on-pump CABG surgery
Having an American Society of Anesthesiologists' (ASA) physical status of 3 to 4
Exclusion Criteria:
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
12. IPD Sharing Statement
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The Effect of BIS Monitorization to Intraoperative Anesthetic Consumption During Coronary Artery Surgery
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