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

General Electric (GE)

Status: Completed

Conditions: Surgical Procedure, Unspecified

Treatments: Device: AoA Monitoring; Device: Routine (Standard) Anesthesia Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928875

123.04-2012-GES-0009

Details and patient eligibility

About

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).

Enrollment: 496 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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496 participants in 2 patient groups

Adequacy of Anesthesia (AoA) Monitoring

Experimental group

Description:

Adequacy of Anesthesia monitoring with SPI and Entropy

Treatment:

Device: AoA Monitoring

Routine (Standard) Anesthesia Monitoring

Active Comparator group

Treatment:

Device: Routine (Standard) Anesthesia Monitoring