AnesthesiaPhase 4NCT01470898
Bispectral Index (BIS) Monitoring in Abdominal Surgery
A Phase 4 study testing bispectral index monitoring in people with Anesthesia, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- bispectral index monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- Feb 2011to Feb 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing major abdominal surgery under general anesthesia in University Hospital Dubrava, were eligible if there were aged 18 years or older
- ASA (American Society of Anesthesiologists) physical status II or III.
Who cannot join
- memory impairment,
- psychosis,
- known or suspected electroencephalograph abnormality (eg, epilepsy, previous brain operation),
- chronic use of psychoactive medication,
- operation time exceeding six hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bispectral Index (BIS) Monitoring on Faster Recovery Time and Analgesic Consumption in Abdominal Surgery Patients
Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. The aim of the study was to investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative anesthesia consumption.
Read the detailed description
Patients undergoing major abdominal surgery under general anesthesia in University Hospital Dubrava, were eligible if there were aged 18 years or older, and ASA (American Society of Anesthesiologists) physical status II or III. Study included 40 patients enroled in the six months period (between February 2011. and July 2011.). Exclusion criteria were memory impairment, psychosis, known or suspected electroencephalograph abnormality (eg, epilepsy, previous brain operation), chronic use of psychoactive medication, and operation time exceeding six hours.
The protocol was approved by Institutional Ethics Committee of University Hospital Dubrava. All participating elective surgical patients were given brief description of the trial, and gave written informed consent before enrolment.
According to a computer generated randomisation list, patients were randomly assigned to receive BIS-guided anesthesia (group 1) or routine anesthesia care as a non BIS-guided group (group 2). The non BIS-guided group was studied while the BIS monitor was attached to patient, but the screen was blinded to the anesthesiologist in charge. All values were recorded by the younger anesthesiologist, who was not involved in the anesthesia maintenance. All other aspects of perioperative treatment were similar, including choice of anesthetic agents and monitoring.
The operation was performed under general anesthesia using midazolam (0.15 mg/kg), fentanyl (2 µg/kg) and pancuronium (0.1 mg/kg) to facilitate endotracheal intubation, and 1.5-2.5 MAC of sevoflurane, nitrous oxide 50% in oxygen, boluses of fentanyl and pancuronium for maintenance. Intraoperatively, after induction doses of fentanyl, anesthesia was mainly balanced with sevoflurane. Electrocardiography (EKG), invasive blood pressure (IBP), peripheral oxygen saturation (SpO2), and end-tidal CO2 (etCO2) were monitored.
A BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation [3].
After the surgery and recovery from anesthesia, patients were transferred to intensive care unit for continuous monitoring of vital functions and homeostasis.
At the induction of anesthesia, and every 15 minutes during operation, BIS levels were recorded. Also, at the end of the operation, extubation time and analgesics consumption were recorded.
- Conditions
- Anesthesia
- Being tested
- bispectral index monitoring
- Keywords
- bispectral index monitoring, extubation, analgesia, abdominal surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bispectral index monitoringDevice
A BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation.At the induction of anesthesia, and every 15 minutes during operation following parameters were recorded: heart rate (HR), systolic blood pressure (BP), end-tidal CO2 (etCO2) and BIS level. Also, operation time and extubation time were recorded. Finally, all patients were visited on the first postoperative day and interviewed about intraoperative recall.
| Study group | Role | What they receive |
|---|---|---|
| anesthesia monitoring | Experimental | Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. A BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation. Receives: Device: bispectral index monitoring |
| no bispectral index monitoring | Experimental | At the induction of anesthesia, and every 15 minutes during operation following parameters were recorded: heart rate (HR), systolic blood pressure (BP), end-tidal CO2 (etCO2) and BIS level. Also, operation time and extubation time were recorded. Finally, all patients were visited on the first postoperative day and interviewed about intraoperative recall. Receives: Device: bispectral index monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bispectral index (BIS) monitoring in abdominal surgery patients
At the induction of anesthesia, and every 15 minutes during operation BIS levels were recorded.
Measured: six months
Secondary outcomes (1)
Effect of bispectral index (BIS) monitoring on faster recovery time in abdominal surgery patients
At the end of operation, time to extubation were measured.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasminka Persec, MD, PhD, University Hospital Dubrava
- Investigators
- Jasminka Persec, MD PhD, Principal investigator, Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, CroatiaZoran Persec, MD PhD, Study chair, Department of urology, University Hospital Dubrava, Zagreb, CroatiaIno Husedzinovic, Professor, Study director, Head of Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470898
- Sponsor's protocol ID
- 12377KBD
- Status last verified
- Nov 2011
- First submitted
- 7 Nov 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Persec J, Persec Z, Kopljar M, Sojcic N, Husedzinovic I. Effect of bispectral index monitoring on extubation time and analgesic consumption in abdominal surgery: a randomised clinical trial. Swiss Med Wkly. 2012 Oct 9;142:w13689. doi: 10.4414/smw.2012.13689. eCollection 2012.
PubMed 23135976
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bispectral Index (BIS) Monitoring on Faster Recovery Time and Analgesic Consumption in Abdominal Surgery Patients
- ClinicalTrials.gov ID
- NCT01470898
- Acronym / sponsor ID
- 12377KBD
- Conditions
- Anesthesia
- Keywords
- bispectral index monitoring, extubation, analgesia, abdominal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2013 (estimated)
- First posted
- 11 Nov 2011 (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.
Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. The aim of the study was to investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative anesthesia consumption.
Detailed description
Patients undergoing major abdominal surgery under general anesthesia in University Hospital Dubrava, were eligible if there were aged 18 years or older, and ASA (American Society of Anesthesiologists) physical status II or III. Study included 40 patients enroled in the six months period (between February 2011. and July 2011.). Exclusion criteria were memory impairment, psychosis, known or suspected electroencephalograph abnormality (eg, epilepsy, previous brain operation), chronic use of psychoactive medication, and operation time exceeding six hours.
The protocol was approved by Institutional Ethics Committee of University Hospital Dubrava. All participating elective surgical patients were given brief description of the trial, and gave written informed consent before enrolment.
According to a computer generated randomisation list, patients were randomly assigned to receive BIS-guided anesthesia (group 1) or routine anesthesia care as a non BIS-guided group (group 2). The non BIS-guided group was studied while the BIS monitor was attached to patient, but the screen was blinded to the anesthesiologist in charge. All values were recorded by the younger anesthesiologist, who was not involved in the anesthesia maintenance. All other aspects of perioperative treatment were similar, including choice of anesthetic agents and monitoring.
The operation was performed under general anesthesia using midazolam (0.15 mg/kg), fentanyl (2 µg/kg) and pancuronium (0.1 mg/kg) to facilitate endotracheal intubation, and 1.5-2.5 MAC of sevoflurane, nitrous oxide 50% in oxygen, boluses of fentanyl and pancuronium for maintenance. Intraoperatively, after induction doses of fentanyl, anesthesia was mainly balanced with sevoflurane. Electrocardiography (EKG), invasive blood pressure (IBP), peripheral oxygen saturation (SpO2), and end-tidal CO2 (etCO2) were monitored.
A BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation [3].
After the surgery and recovery from anesthesia, patients were transferred to intensive care unit for continuous monitoring of vital functions and homeostasis.
At the induction of anesthesia, and every 15 minutes during operation, BIS levels were recorded. Also, at the end of the operation, extubation time and analgesics consumption were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anesthesia monitoring | Experimental | Device: bispectral index monitoringBispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. A BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation. |
| no bispectral index monitoring | Experimental | Device: bispectral index monitoringAt the induction of anesthesia, and every 15 minutes during operation following parameters were recorded: heart rate (HR), systolic blood pressure (BP), end-tidal CO2 (etCO2) and BIS level. Also, operation time and extubation time were recorded. Finally, all patients were visited on the first postoperative day and interviewed about intraoperative recall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing major abdominal surgery under general anesthesia in University Hospital Dubrava, were eligible if there were aged 18 years or older
- ASA (American Society of Anesthesiologists) physical status II or III.
Key exclusion criteria (5 listed)
- memory impairment,
- psychosis,
- known or suspected electroencephalograph abnormality (eg, epilepsy, previous brain operation),
- chronic use of psychoactive medication,
- operation time exceeding six hours.
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 |
|---|---|---|
| bispectral index monitoringA BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation.At the induction of anesthesia, and every 15 minutes during operation following parameters were recorded: heart rate (HR), systolic blood pressure (BP), end-tidal CO2 (etCO2) and BIS level. Also, operation time and extubation time were recorded. Finally, all patients were visited on the first postoperative day and interviewed about intraoperative recall. | Device | anesthesia monitoring, no bispectral index monitoring |
Primary outcome
Bispectral index (BIS) monitoring in abdominal surgery patients
Time frame: six months
At the induction of anesthesia, and every 15 minutes during operation BIS levels were recorded.
1 secondary outcome
Effect of bispectral index (BIS) monitoring on faster recovery time in abdominal surgery patients
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Derived from this study: PubMed 23135976Persec J, Persec Z, Kopljar M, Sojcic N, Husedzinovic I. Effect of bispectral index monitoring on extubation time and analgesic consumption in abdominal surgery: a randomised clinical trial. Swiss Med Wkly. 2012 Oct 9;142:w13689. doi: 10.4414/smw.2012.13689. eCollection 2012.
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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.
Jasminka Persec, MD PhD principal investigator
Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia
Zoran Persec, MD PhD study chair
Department of urology, University Hospital Dubrava, Zagreb, Croatia
Ino Husedzinovic, Professor study director
Head of Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bispectral index monitoring in people with Anesthesia, run by University Hospital Dubrava at 1 site in Croatia.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Bispectral index (BIS) monitoring in abdominal surgery patients (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470898, which also lists 1 linked publication.
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 10 Jul 2012.