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OpenTrials
Completed

NCT Number: NCT03970291

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaare Zedek Medical Center

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia, e.g. transversus abdominal plane block)
  • Patients with rhythm other than sinus cardiac rhythm, implanted pacemakers, α2-adrenergic agonists and β1-adrenergic antagonists
  • Pregnancy/lactation
  • Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures)
  • Abuse of alcohol or illicit drugs within the last 6 months
  • 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.
  • 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
  • Chronic use of psychoactive drugs within 90 days prior to surgery
  • Allergy or intolerance to any of the study drugs
  • History of severe cardiac arrhythmias within the last 12 months

Treatment and study plan

PMD-200

Device

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)

Primary outcomes

  1. Pain score

    Time frame: Through study completion, about 8 months

    Change in pain score in the PACU using the visual analog scale (VAS)

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Medasense Biometrics Ltd

Other

Registry information

Official study title

Impact of Nociceptive-Level (NOL) Intraoperative Guided Fentanyl Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 31, 2019
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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