NCT03970291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 1, 2022

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

May 28, 2019

Last Update Submit

January 16, 2022

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Pain score

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

    Through study completion, about 8 months

Secondary Outcomes (2)

  • Inadequate analgesia/anesthesia events

    Through study completion, about 8 months

  • Total intraoperative fentanyl

    Through study completion, about 8 months

Study Arms (2)

Nociceptive-Level (NOL)

EXPERIMENTAL

Analgesic component of anesthesia (fentanyl) will be guided using NOL

Device: PMD-200

Standard Clinical Care (SCC)

NO INTERVENTION

Standard Clinical Care guided fentanyl administration

Interventions

PMD-200DEVICE

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)

Nociceptive-Level (NOL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (1)

  • Fuica R, Krochek C, Weissbrod R, Greenman D, Freundlich A, Gozal Y. Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial. J Clin Monit Comput. 2023 Apr;37(2):481-491. doi: 10.1007/s10877-022-00906-1. Epub 2022 Aug 17.

    PMID: 35976578DERIVED

Study Officials

  • Dr Rivka Leah Fuica, MD

    Shaare Zedek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

May 31, 2019

Study Start

November 1, 2019

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

February 1, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)