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Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01928875
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : May 1, 2017
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).

Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Device: AoA Monitoring Device: Routine (Standard) Anesthesia Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia
Study Start Date : December 2013
Actual Primary Completion Date : February 1, 2017

Arm Intervention/treatment
Experimental: Adequacy of Anesthesia (AoA) Monitoring
Adequacy of Anesthesia monitoring with SPI and Entropy
Device: AoA Monitoring
Monitoring with Entropy and SPI parameters during surgery

Active Comparator: Routine (Standard) Anesthesia Monitoring Device: Routine (Standard) Anesthesia Monitoring
Standard of care monitoring

Primary Outcome Measures :
  1. Incidence of hemodynamic instability [ Time Frame: Participants will be followed for the duration of their surgery ]
    Incidence of hemodynamic instability including hypertension, hypotension, tachycardia, and bradycardia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to provide written informed consent
  • Age 18-80 years of age
  • Surgery that is expected to last at least 2 hours under general anesthesia with endotracheal tube

Exclusion Criteria:

  • Any subject that meets the definition of vulnerable subject as defined in ISO 14155:2011
  • Per ISO 14155:2011, a vulnerable subject is defined as an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate
  • Any subject with a cardiac pacemaker
  • Any subject with atrial fibrillation at the time of obtaining the baseline values
  • Any subject with more than 5 ventricular extra systoles/minute at the time of obtaining the baseline values
  • Any subject who needs invasive blood pressure measurement
  • Any subject who show hemodynamics that would have qualified for being considered as a sign of inadequate anesthesia already at baseline:
  • Mean blood pressure below 60 mmHg or above 100 mmHg
  • HR below 45 /min or above 100/min
  • Any subject with epidural anesthesia or analgesia during the surgery. Epidural catheter may be placed pre-operatively, and used in the PACU, but not during the surgery
  • Any subject having surgery that requires prone position
  • Any subject with very high body mass index (>35) because of incompatibility with the target controlled anesthesia models used
  • Any subject with known allergies to the specific anesthetic agents/ analgesic drugs intended for use in their surgeries
  • Any subject with laryngeal mask airway
  • Any subject who requires neuromuscular blocking agent infusion
  • Any subject who is going to have major surgery with a high risk of extensive blood loss
  • Any subject with known chronic use of opioids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01928875

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Tampere University Hospital
Tampere, Finland
University Hospital Schleswig-Holstein
Kiel, Germany, 24105
University of Szeged
Szeged, Hungary
University of Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
GE Healthcare
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GE Healthcare Identifier: NCT01928875    
Other Study ID Numbers: 123.04-2012-GES-0009
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs