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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912118
• Other study ID #: NL43511.058.13
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: April 2, 2015
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Intervention

Drug:
• Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
• Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Medasense Biometrics Ltd

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

Treister R, Kliger M, Zuckerman G, Goor Aryeh I, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-14. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nociception level index (NoI)	The NoL measures the magnitude of the autonomic responses to painful stimuli. The NoL combines information from several physiological parameters which represent different autonomic pathways.	Between induction and first incision	No
Secondary	Cardiovascular parameters	Individual pain related cardiovascular parameters, as heart rate, blood pressure and PPG wave amplitude.	Between induction and first incision	No
Secondary	Movement	Visible occurence of movement during painfull stimuli.	Between induction and first incision	No
Secondary	Depth of anesthesia	Depth of anesthesia is measured by a Bispectral Index monitor. Changes in depth of anesthesia will be recorded during painfull stimuli	Between induction and first incision	No