CompletedNot Applicable

Surgical Intervention in Deep Sedation: No Pain or no Memory

Italy36 participantsStarted 2024-03-01

Plain-language summary

The goal of this observational study is to assess the levels of nociception in deeply sedated patients who need painful and short-duration surgical procedure. The main question it aims to answer is to verify that the sedative protocols used in clinical practice are sufficiently effective also in terms of nociception. Participants will deeply sedated and monitored with PMD-200™ to detect the nociception level (NOL Index).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patient * ASA Physical Status I - II - III Exclusion Criteria: * ASA Physical Status IV * Pregnant and breastfeeding patients * Pre-existing cardiac arrhythmias * Patients with neuromuscular diseases * Patients with psychiatric syndromes under pharmacological treatment * Patients with chronic use of analgesics * Patients with a history of drug abuse * Allergy to one or more drugs used in the protocol * Refusal to consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

High level of nociception

Timeframe: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.

Trial details

NCT IDNCT06963749

SponsorASL Novara

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Pain, Acute trials