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Bispectral Index (BIS) Monitoring in Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT01470898
Recruitment Status : Unknown
Verified November 2011 by Jasminka Persec, MD, PhD, University Hospital Dubrava.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2011
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Jasminka Persec, MD, PhD, University Hospital Dubrava

November 7, 2011
November 11, 2011
July 10, 2012
February 2011
July 2011   (Final data collection date for primary outcome measure)
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.
Effect of bispectral index (BIS) monitoring on faster recovery time and analgesic consumption in abdominal surgery patients [ Time Frame: six months ]
At the induction of anesthesia, and every 15 minutes during operation BIS levels were recorded.
Complete list of historical versions of study NCT01470898 on ClinicalTrials.gov Archive Site
Effect of bispectral index (BIS) monitoring on faster recovery time in abdominal surgery patients [ Time Frame: six months ]
At the end of operation, time to extubation were measured.
  • Effect of bispectral index (BIS) monitoring on faster recovery time and analgesic consumption in abdominal surgery patients [ Time Frame: six months ]
    At the end of operation, time to extubation were measured.
  • Effect of bispectral index (BIS) monitoring on faster recovery time and analgesic consumption in abdominal surgery patients [ Time Frame: six months ]
    At the end of the operation, intraoperative analgesics consumption were measured.
Not Provided
Not Provided
 
Bispectral Index (BIS) Monitoring in Abdominal Surgery
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Anesthesia
Device: bispectral index monitoring
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.
  • Experimental: anesthesia monitoring
    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.
    Intervention: Device: bispectral index monitoring
  • Experimental: no bispectral index monitoring
    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.
    Intervention: Device: bispectral index monitoring
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
February 2013
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • memory impairment,
  • psychosis,
  • known or suspected electroencephalograph abnormality (eg, epilepsy, previous brain operation),
  • chronic use of psychoactive medication,
  • operation time exceeding six hours.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
 
NCT01470898
12377KBD
No
Not Provided
Not Provided
Jasminka Persec, MD, PhD, University Hospital Dubrava
University Hospital Dubrava
Not Provided
Principal Investigator: Jasminka Persec, MD PhD Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia
Study Chair: Zoran Persec, MD PhD Department of urology, University Hospital Dubrava, Zagreb, Croatia
Study Director: Ino Husedzinovic, Professor Head of Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia
University Hospital Dubrava
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP