Bispectral Index (BIS) Monitoring in Abdominal Surgery
Information source: University Hospital Dubrava
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia
Intervention: bispectral index monitoring (Device)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University Hospital Dubrava Official(s) and/or principal investigator(s): Jasminka Persec, MD PhD, Principal Investigator, Affiliation: Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia Zoran Persec, MD PhD, Study Chair, Affiliation: Department of urology, University Hospital Dubrava, Zagreb, Croatia Ino Husedzinovic, Professor, Study Director, Affiliation: Head of Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia
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.
Clinical Details
Official title: Effect of Bispectral Index (BIS) Monitoring on Faster Recovery Time and Analgesic Consumption in Abdominal Surgery Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Bispectral index (BIS) monitoring in abdominal surgery patients
Secondary outcome: Effect of bispectral index (BIS) monitoring on faster recovery time in abdominal surgery patients
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University Hospital Dubrava, Zagreb 10000, Croatia
Additional Information
Starting date: February 2011
Last updated: July 9, 2012
|