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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Croatia1 site
  • University Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

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 groups in NCT01470898
Study groupRoleWhat they receive
anesthesia monitoringExperimentalBispectral 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 monitoringExperimentalAt 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.

  1. 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)
  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.

  1. First posted11 Nov 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionJul 2011
  4. Study completionFeb 2013 (estimated)

Resources

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)
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

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.

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