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Impact of NOL Intraoperative Guided Fentanyl Analgesia vs SCC for Elective Major Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03970291
Recruitment Status : Not yet recruiting
First Posted : May 31, 2019
Last Update Posted : August 13, 2019
Information provided by (Responsible Party):
Medasense Biometrics Ltd

Brief Summary:

Recently, a newly developed index, the Nociceptive Level (NOL) index, was validated and showed superiority over heart rate and blood pressure for recognition and grading of intense and mild nociceptive stimuli during surgery under general anesthesia.

We hypothesize that compared with standard management, NOL-guided anesthesia will lead to reduced postoperative pain scores, and during anesthesia, to increased hemodynamic stability.

Condition or disease Intervention/treatment Phase
Anesthesia Device: PMD-200 Not Applicable

Detailed Description:

Uncontrolled postoperative pain may result in significant clinical, psychological, and socioeconomics consequences. Not only does inadequate pain management following surgery result in increased morbidity and mortality but it also may delay recovery, result in unanticipated readmissions, decrease patient satisfaction, and lead to chronic persistent postsurgical pain. Pain is multifactorial in nature and understanding both the complexity of pain and its side effects is imperative to achieve a successful surgical outcome.

Nociception/analgesia are currently assessed by monitoring changes in heart rate (HR), blood pressure (BP), and other indirect parameters which are not sensitive or specific to nociception. As a result, the patient may be given insufficient analgesia which can promote postoperative pain, or excessive analgesia which can result in overdosing and related complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Nociceptive-Level (NOL) Intraoperative Guided Fentanyl Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : February 27, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nociceptive-Level (NOL)
Analgesic component of anesthesia (fentanyl) will be guided using NOL
Device: PMD-200
The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)

No Intervention: Standard Clinical Care (SCC)
Standard Clinical Care guided fentanyl administration

Primary Outcome Measures :
  1. Pain score [ Time Frame: Through study completion, about 8 months ]
    Change in pain score in the PACU using the visual analog scale (VAS)

  2. Hypotension episodes [ Time Frame: Through study completion, about 8 months ]
    Change of hypotension episodes (MAP < 55 mmHg and/or < 60 mmHg) during the maintenance period until reversal

Secondary Outcome Measures :
  1. Inadequate analgesia/anesthesia events [ Time Frame: Through study completion, about 8 months ]
    Change in frequency of Inadequate analgesia/anesthesia events*

  2. Total intraoperative fentanyl [ Time Frame: Through study completion, about 8 months ]
    Change in total intraoperative fentanyl consumption (in mcg).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age > 18 years old.
  2. ASA I-III
  3. Elective major laparoscopic abdominal surgical, urologic or gynecologic procedures under general anesthesia.
  4. Patient able to provide informed consent

Exclusion Criteria:

  1. Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia, e.g. transversus abdominal plane block)
  2. Patients with rhythm other than sinus cardiac rhythm, implanted pacemakers, α2-adrenergic agonists and β1-adrenergic antagonists
  3. Pregnancy/lactation
  4. Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures)
  5. Abuse of alcohol or illicit drugs within the last 6 months
  6. Chronic pain conditions - pain in 1 or more anatomic regions that persists or recurs for longer than 3 months and is associated with significant emotional distress or significant functional disability.
  7. Opioid tolerant - if for at least 1 week the patient has been receiving oral morphine 60 mg/day; transdermal fentanyl 25 mcg/hour; oral hydromorphone 8 mg/day; oral oxymorphone 25 mg/day; or an equianalgesic dose of any other opioid
  8. Chronic use of psychoactive drugs within 90 days prior to surgery
  9. Allergy or intolerance to any of the study drugs
  10. History of severe cardiac arrhythmias within the last 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03970291

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Contact: Rachel Weissbrod 972-737690321

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Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Rivka Leah Fuica, MD    972-2-6555104   
Principal Investigator: Rivka Leah Fuica, MD         
Sponsors and Collaborators
Medasense Biometrics Ltd
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Principal Investigator: Dr Rivka Leah Fuica, MD Shaare Zedek

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Responsible Party: Medasense Biometrics Ltd Identifier: NCT03970291     History of Changes
Other Study ID Numbers: CLI-01-1-08
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General