- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03970291
Impact of NOL Intraoperative Guided Fentanyl Analgesia vs SCC for Elective Major Abdominal Surgery
Impact of Nociceptive-Level (NOL) Intraoperative Guided Fentanyl Analgesia Versus Standard Clinical Care (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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Jerusalem, Israel
- Shaare Zedek Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nociceptive-Level (NOL)
Analgesic component of anesthesia (fentanyl) will be guided using NOL
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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)
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No Intervention: Standard Clinical Care (SCC)
Standard Clinical Care guided fentanyl administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: Through study completion, about 8 months
|
Change in pain score in the PACU using the visual analog scale (VAS)
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Through study completion, about 8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inadequate analgesia/anesthesia events
Time Frame: Through study completion, about 8 months
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Change in frequency of Inadequate analgesia/anesthesia events*
|
Through study completion, about 8 months
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Total intraoperative fentanyl
Time Frame: Through study completion, about 8 months
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Change in total intraoperative fentanyl consumption (in mcg).
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Through study completion, about 8 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Rivka Leah Fuica, MD, Shaare Zedek
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CLI-01-1-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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