Comparison of Adequacy of Anesthesia Monitoring with Standard Clinical Practice during Routine General Anesthesia

Completed

• Conditions: specifieke aandoeningen zijn niet van belang voor het onderzoek; N.A.

• Registration Number: NL-OMON38660
• Lead Sponsor: GE Healthcare Attn: Petra Peltola, Clinical Research Manager

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

• 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 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
• 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 is going to have major surgery with a high risk of extensive blood loss
• Any subject with known chronic use of opioids

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Incidence of hemodynamic instability including hypertension, hypotension,<br /><br>tachycardia and bradycardia<br /><br>• Incidence of subject movements including somatic arousal, somatic response</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Amount of anesthetic and analgesic drugs used<br /><br>• Time points of the operation (start of monitoring, induction, loss of<br /><br>consciousness, intubation, start of surgery, maximum surgical stimuli, end of<br /><br>surgery, discontinuation of anesthetics, open eyes on verbal command (emergence<br /><br>from anesthesia), extubation)<br /><br>• In the recovery room, the modified Aldrete-Score, postoperative nausea and<br /><br>vomiting, and pain using a 0-10 numerical pain intensity rating (Visual Analog<br /><br>Scale, VAS) scale are recorded.<br /><br>• On the first postoperative day, all subjects are asked by a blinded<br /><br>investigator if they had any memory or awareness during anesthesia and the<br /><br>level of satisfaction with the whole surgical procedure using a 0-100 scale.<br /><br>• SPI and Entropy values from the test group</p><br>