Bispectral Index (BIS) Monitoring in Abdominal Surgery

NCT01470898 | Unknown Phase 4

• 1 other identifier: 12377KBD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. The aim of the study was to investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative anesthesia consumption.

Conditions

Anesthesia

Keywords

bispectral index monitoring; extubation; analgesia; abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Bispectral index (BIS) monitoring in abdominal surgery patients

  At the induction of anesthesia, and every 15 minutes during operation BIS levels were recorded.

  six months

Secondary Outcomes (1)

• Effect of bispectral index (BIS) monitoring on faster recovery time in abdominal surgery patients

  six months

Study Arms (2)

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.

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.

Device: bispectral index monitoring

Interventions

bispectral index monitoring DEVICE

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.

anesthesia monitoring; no bispectral index monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• memory impairment,
• psychosis,
• known or suspected electroencephalograph abnormality (eg, epilepsy, previous brain operation),
• chronic use of psychoactive medication,
• operation time exceeding six hours.

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 23135976 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jasminka Persec, MD PhD

  Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia

  PRINCIPAL INVESTIGATOR

• Zoran Persec, MD PhD

  Department of urology, University Hospital Dubrava, Zagreb, Croatia

  STUDY CHAIR

• Ino Husedzinovic, Professor

  Head of Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 11, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2013
• Last Updated: July 10, 2012

Record last verified: 2011-11

Locations

CR (1)