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

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).

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Device: AoA Monitoring; Device: Routine (Standard) Anesthesia Monitoring

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • Tampere University Hospital
• Germany
  • Kiel, Germany, 24105
    • University Hospital Schleswig-Holstein
• Hungary
  • Szeged, Hungary
    • University of Szeged
• Netherlands
  • Amsterdam, Netherlands
    • University of Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hemodynamic instability	Incidence of hemodynamic instability including hypertension, hypotension, tachycardia, and bradycardia	Participants will be followed for the duration of their surgery

Collaborators and Investigators

• Sponsor: GE Healthcare

Publications and helpful links

General Publications

• Gruenewald M, Harju J, Preckel B, Molnar Z, Yli-Hankala A, Rosskopf F, Koers L, Orban A, Bein B; AoA Study Group. Comparison of adequacy of anaesthesia monitoring with standard clinical practice monitoring during routine general anaesthesia: An international, multicentre, single-blinded randomised controlled trial. Eur J Anaesthesiol. 2021 Jan;38(1):73-81. doi: 10.1097/EJA.0000000000001357.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 123.04-2012-GES-0009