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 range18 Years

SexALL

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

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