CompletedNot Applicable

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

Israel95 participantsStarted 2019-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Pain score

Timeframe: Through study completion, about 8 months

Trial details

NCT IDNCT03970291

SponsorMedasense Biometrics Ltd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-30

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