Unconscious StateNCT02520947
The Effect of BIS Monitorization to Intraoperative Anesthetic Consumption During Coronary Artery Surgery
A study testing BIS and Desflurane in people with Unconscious State, run by Baskent University Ankara Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Unconscious State
- What is being tested?
- BIS and Desflurane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing elective on-pump CABG surgery
- Having an American Society of Anesthesiologists' (ASA) physical status of 3 to 4
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: The Effect of BIS Monitorization to Intraoperative Anesthetic and Analgesic Consumption During Coronary Artery Grafting Surgery and Postoperative Mortality and Morbidity
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.
Read the 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.
- Conditions
- Unconscious State
- Being tested
- BIS, Desflurane
- Keywords
- desflurane, BIS, coronary artery bypass grafting surgery
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BISDevice
Also called processed electroencephalograpy
Bispectral index monitoring
DesfluraneDrug
Also called suprane
volatile agent for maintenance of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Bispectral index | Experimental | The group that desflurane titrated according to bispectral index monitoring Receives: Device: BIS; Drug: Desflurane |
| Minimum alveolar concentration | Other | The group that desflurane consumption titrated according to minimum alveolar concentration monitoring Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and hourly amounts of desflurane consumption
A more than 20 % reduction in total and hourly amounts of desflurane consumption
Measured: up to 12 hours
Secondary outcomes (3)
Time to extubation
participants was followed for the duration of extubation
Measured: up to 2 days
Mortality
participants was followed for 28 days after surgery
Measured: 28 days
Morbidity
participants was followed for 28 days after surgery for any systemic complications
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unconscious StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kaval, Baskent University Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520947
- Sponsor's protocol ID
- BIS-12345
- Status last verified
- Aug 2015
- First submitted
- 5 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BIS Monitorization to Intraoperative Anesthetic and Analgesic Consumption During Coronary Artery Grafting Surgery and Postoperative Mortality and Morbidity
- ClinicalTrials.gov ID
- NCT02520947
- Acronym / sponsor ID
- BIS-12345
- Conditions
- Unconscious State
- Keywords
- desflurane, BIS, coronary artery bypass grafting surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bispectral index | Experimental | Device: BIS, Drug: DesfluraneThe group that desflurane titrated according to bispectral index monitoring |
| Minimum alveolar concentration | Other | Drug: DesfluraneThe group that desflurane consumption titrated according to minimum alveolar concentration monitoring |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing elective on-pump CABG surgery
- Having an American Society of Anesthesiologists' (ASA) physical status of 3 to 4
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BISAlso: processed electroencephalograpyBispectral index monitoring | Device | Bispectral index |
| DesfluraneAlso: supranevolatile agent for maintenance of anesthesia | Drug | Bispectral index, Minimum alveolar concentration |
Primary outcome
Total and hourly amounts of desflurane consumption
Time frame: up to 12 hours
A more than 20 % reduction in total and hourly amounts of desflurane consumption
3 secondary outcomes
Time to extubation
Time frame: up to 2 days
Mortality
Time frame: 28 days
Morbidity
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BIS and Desflurane in people with Unconscious State, run by Baskent University Ankara Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and hourly amounts of desflurane consumption (time frame: up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.