Clinical trial NCT01912118: The Medasense Study
Official title: Measurement of Nociceptive Index During General Anesthesia in ASA 1-3 Patients Undergoing Elective Surgery Using the Nociception Level (NoL) Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Nociception
General anesthesia
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Medasense Biometrics Ltd
First posted: 2013-07-30
Enrollment: 96
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: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age: 18-80 years;
* Sex: male or female;
* Surgery: Any surgery under general anesthesia;
* ASA status: 1, 2 or 3.

Exclusion Criteria:

* Age: \< 18 or \> 80 years;
* Unable to give written informed consent;
* Pregnancy/lactation;
* Extreme obesity: BMI \> 35;
* Perceived difficult intubation.
* Patients requiring a rapid sequence induction
* Patients on beta-blockers

Primary outcomes:
measure: Nociception level index (NoI)
timeFrame: Between induction and first incision
Secondary outcomes:
measure: Cardiovascular parameters
timeFrame: Between induction and first incision
measure: Movement
timeFrame: Between induction and first incision
measure: Depth of anesthesia
timeFrame: Between induction and first incision
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Albert Dahan, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
citation: Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.