NCT01912118

The Medasense Study

Measurement of Nociceptive Index During General Anesthesia in ASA 1-3 Patients Undergoing Elective Surgery Using the Nociception Level (NoL) Index

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Despite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. In a previous protocol the investigators measured pain responses during anesthesia based on single end-points, eg heart rate,blood pressure and pulse transit time. None of these parameters provided sufficient information regarding nociception. The investigators therefore want to further investigate this matter using a composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the magnitude of the autonomic response to painful stimuli. The NoL combines information from several physiological parameters, which represent different autonomic pathways. The multi-parameter approach empowered with state-of-the-art signal processing and machine learning techniques. In the current study the investigators will measure the NoL in ASA 1-3 patients undergoing elective surgery under general anesthesia. The investigators will measure NoL responses and the occurrence of patient movement upon the administration of a painful stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of the gastric tube, Insertion of the bladder catheter and Skin incision.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Propofol	Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
DRUG	Remifentanil	Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-06-01
• Completion: 2014-09-01
• First posted: 2013-07-30
• Last updated: 2015-04-06

Locations

1 site across 1 country: Netherlands