Clinical trial NCT01928875: Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia
Official title: Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hemodynamic instability
timeFrame: Participants will be followed for the duration of their surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Szeged
country: Hungary
facility: University of Szeged
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
Study officials:
References:
citation: 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.