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Recording the level of analgesia in intensive care patients - is the measurement of the RIII-reflex a useful addition to the established categorical pain detection scales in non-communicative patients?

Recording the level of analgesia in intensive care patients - is the measurement of the RIII-reflex a useful addition to the established categorical pain detection scales in non-communicative patients?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021149
Enrollment
210
Registered
2020-03-26
Start date
2018-11-12
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detection of the nociceptive flexor reflex in the analgosedated intensive care patient Incidence of delirium Mortality rates Assessment of the thresholds in different subgroups

Interventions

Group 1: Simple randomization using a random table Recording the behavioral pain scale and the secondary parameters in intubated and analgosedated intensive care patients. First measurement within 12

Sponsors

Klinik für Anästhesiologie - Interdisziplinäre Operative Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Men and women aged> 18 years At the time of data collection, the patient is ventilated and analgosedated Post-hoc information or consent from the patients legal designees

Exclusion criteria

Exclusion criteria: pregnancy age <18 years neurological diseases that are associated with a restriction of peripheral conduction, such as Cross-sectional symptoms muscular dystrophy polyneuropathy (also in advanced diabetes mellitus, C2 abuse) Critical illness polyneuropathy (CIP) - clinical suspicion, Multiple sclerosis, Guillain-Barré syndrome, denervating neurological Diseases Cardiac pacemakers or electrical defibrillators - so far no damage to such devices has been demonstrated by the applied currents. We want to avoid any potential damage to the devices and thus endanger the patient! subsequently withdrawn consent to study participation Patients who have already been included in the study and who have to be re-admitted to the intensive care unit after transfer from the ICU will not be included in the study again.

Design outcomes

Primary

MeasureTime frame
Does the measurement of the nociceptive flexor reflex, measured on a heterogeneous collective of ventilated and analgosedated intensive care patients, correlate with the BPS? Is it possible to detect overanalgesia by measuring the nociceptive flexor reflex in the corresponding study group? (In this context, overanalgesia is defined as exceeding the postulated stimulus threshold of 20 mA).

Secondary

MeasureTime frame
Does the supplementary measurement of the nociceptive flexor reflex reduce the incidence of delirium compared to the patient group in which the level of analgesia is measured exclusively by means of BPS and the level of sedation by means of RASS? Does the measurement of the nociceptive flexor reflex in the corresponding patient group compared to the patients in whom the level of analgesia is only measured by BPS leads to a shorter duration of ventilation? Do genetic polymorphisms exist that affect the pain threshold in critically ill patients? Is there a correlation between the patient's individual stimulus threshold, genetic polymorphism and analgesic regimen?

Countries

Germany

Contacts

Public ContactBenedikt Zujalovic

Universitätsklinikum UlmKlinik für Anästhesiologie

benedikt.zujalovic@uniklinik-ulm.de073150060245

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 20, 2026