Performance Assessment of the PMD-200 Under General Anesthesia

NCT03467230 | Completed DMC

• 1 other identifier: 18-0302
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the nociceptive/antinociceptive state. The purpose of this project is to conduct an observational study of the PMD-200 noninvasive monitor (Medasense Biometrics Ltd., Ramat Gan, Israel), As this is an observational study, this monitor will not be used for clinical decision making, and the point of the study is to assess what happens with the NoL index during routine care. After thorough discussion with patients and written informed consent is provided in the pre-operative unit, patients will be transferred to the operating room. Patients will be connected to a vital sign monitor and any other medical equipment needed for the surgical procedure, as required by the standard of practice. The PMD-200 finger probe will be connected to the left hand middle finger (or right). The PMD-200 will be activated after the induction of general anesthesia. A calibration period of 1-2 minutes will be performed. At the conclusion of the surgical procedure, the PMD200 will be disconnected from the patient. All the phases of anesthetic care are performed at the discretion of the anesthesiologist, but the time of administration of analgesics, muscle relaxants and other medications during anesthetic care will be recorded. The investigators will also record the time point of intubation (placement of breathing tube), extubation (removal of breathing tube), skin incision and any other significant surgical stimulation or noxious stimulation during the procedure. The investigators will be comparing NOL values prior to and following noxious stimuli, administration of analgesic agents and during non-noxious periods.

Conditions

Pain; Opioid Use; Intraoperative Complications

Outcome Measures

Primary Outcomes (1)

• The primary efficacy objective: Correlation of NoL Index with noxious stimulation/analgesic use

  To demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration). Specifically, the investigators will assess the % change from baseline-steady state NoL Index value with the NoL Index value during surgical stimulation (increased noxious stimulation) as well as the NoL Index value after administration of analgesics (decreased noxious stimulation).

  Intraoperatively

Secondary Outcomes (3)

• the secondary efficacy objective: Correlation of NoL Index with changes in heart rate

  Intraoperatively

• the secondary efficacy objective: Correlation of NoL Index with blood pressure

  Intraoperatively

• Safety objective: Any adverse reaction related to device

  Intraoperatively

Study Arms (1)

NoL Index

All patients will be monitored by PMD-200 device

Device: NoL Index

Interventions

NoL Index DEVICE

Use of the PMD-200 in an observational study

NoL Index

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients ASA I-III scheduled for general anesthesia for laparoscopic GI or GU procedures.

You may qualify if:

• Age \> 18 years old.
• Requiring laparoscopic gastrointestinal or laparoscopic hysterectomy under general anesthesia (without regional anesthesia)
• Patient provides informed consent

You may not qualify if:

• History of severe cardiac arrhythmias within the last 12 months
• Chronic pain conditions or analgesic usage (\>1 month of large doses of opioids: more than 30mg oral equivalent of morphine)

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (13)

• 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.

  PMID: 23835792 BACKGROUND

• Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.

  PMID: 26154185 BACKGROUND

• Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.

  PMID: 27171828 BACKGROUND

• Rantanen M, Yli-Hankala A, van Gils M, Ypparila-Wolters H, Takala P, Huiku M, Kymalainen M, Seitsonen E, Korhonen I. Novel multiparameter approach for measurement of nociception at skin incision during general anaesthesia. Br J Anaesth. 2006 Mar;96(3):367-76. doi: 10.1093/bja/ael005. Epub 2006 Jan 23.

  PMID: 16431883 BACKGROUND

• Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-477. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. No abstract available.

  PMID: 18583048 BACKGROUND

• Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.

  PMID: 23223772 BACKGROUND

• Salo M. Effects of anaesthesia and surgery on the immune response. Acta Anaesthesiol Scand. 1992 Apr;36(3):201-20. doi: 10.1111/j.1399-6576.1992.tb03452.x.

  PMID: 1574967 BACKGROUND

• Libby P. Inflammation in atherosclerosis. Nature. 2002 Dec 19-26;420(6917):868-74. doi: 10.1038/nature01323.

  PMID: 12490960 BACKGROUND

• Vallejo R, Hord ED, Barna SA, Santiago-Palma J, Ahmed S. Perioperative immunosuppression in cancer patients. J Environ Pathol Toxicol Oncol. 2003;22(2):139-46. doi: 10.1615/jenvpathtoxoncol.v22.i2.70.

  PMID: 14533877 BACKGROUND

• Tsuchiya Y, Sawada S, Yoshioka I, Ohashi Y, Matsuo M, Harimaya Y, Tsukada K, Saiki I. Increased surgical stress promotes tumor metastasis. Surgery. 2003 May;133(5):547-55. doi: 10.1067/msy.2003.141.

  PMID: 12773983 BACKGROUND

• Page GG, Ben-Eliyahu S. The immune-suppressive nature of pain. Semin Oncol Nurs. 1997 Feb;13(1):10-5. doi: 10.1016/s0749-2081(97)80044-7.

  PMID: 9048431 BACKGROUND

• Crozier TA, Muller JE, Quittkat D, Sydow M, Wuttke W, Kettler D. Effect of anaesthesia on the cytokine responses to abdominal surgery. Br J Anaesth. 1994 Mar;72(3):280-5. doi: 10.1093/bja/72.3.280.

  PMID: 8130044 BACKGROUND

• Corsi M, Mariconti P, Calvillo L, Falchi M, Tiengo M, Ferrero ME. Influence of inhalational, neuroleptic and local anaesthesia on lymphocyte subset distribution. Int J Tissue React. 1995;17(5-6):211-7.

  PMID: 8835632 BACKGROUND

MeSH Terms

Conditions

Pain; Intraoperative Complications

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Borzoo Farhang, DO

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 15, 2018
• Study Start: March 15, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)