NCT01928875

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).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P75+ for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

3.2 years

First QC Date

August 19, 2013

Last Update Submit

April 28, 2017

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

  • Incidence of hemodynamic instability

    Incidence of hemodynamic instability including hypertension, hypotension, tachycardia, and bradycardia

    Participants will be followed for the duration of their surgery

Study Arms (2)

Adequacy of Anesthesia (AoA) Monitoring

EXPERIMENTAL

Adequacy of Anesthesia monitoring with SPI and Entropy

Device: AoA Monitoring

Routine (Standard) Anesthesia Monitoring

ACTIVE COMPARATOR
Device: Routine (Standard) Anesthesia Monitoring

Interventions

AoA MonitoringDEVICE

Monitoring with Entropy and SPI parameters during surgery

Adequacy of Anesthesia (AoA) Monitoring
Routine (Standard) Anesthesia MonitoringDEVICE

Standard of care monitoring

Routine (Standard) Anesthesia Monitoring

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tampere University Hospital

Tampere, Finland

Location

University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Location

University of Szeged

Szeged, Hungary

Location

University of Amsterdam

Amsterdam, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 33074943DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 27, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2017

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

DE(1)FI(1)HU(1)NL(1)