The Medasense Study

Pain Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

• NCT number: NCT01912118
• Study type: Interventional
• Source: Leiden University Medical Center
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Completion date: September 2014