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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970291
• Other study ID #: CLI-01-1-08
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a2-adrenergic agonists and ß1-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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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)

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Change in pain score in the PACU using the visual analog scale (VAS)	Through study completion, about 8 months
Secondary	Inadequate analgesia/anesthesia events	Change in frequency of Inadequate analgesia/anesthesia events*	Through study completion, about 8 months
Secondary	Total intraoperative fentanyl	Change in total intraoperative fentanyl consumption (in mcg).	Through study completion, about 8 months