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Comparison of Nociception Level Index (NOL®) and qNOX® Index during Outpatient Procedures

Comparison of Nociception Level Index (NOL®) and qNOX® Index during Outpatient Procedures - NOXOUT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037069
Enrollment
50
Registered
2025-06-02
Start date
2025-06-02
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Perioperative nociception under general anesthesia during elective outpatient surgery.

Interventions

Group 1: In planned outpatient surgeries (e.g., ACL reconstruction), patients’ responses to typical stimuli such as skin incision or drug administration are simultaneously measured and compared during

Sponsors

Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Procedure type Scheduled outpatient procedure (elective ACL reconstruction) 3. Anesthesia method General anesthesia, optionally combined with: – Local anesthesia – Infiltration anesthesia – Regional nerve block 4. Informed consent Ability to give consent; standard preoperative information provided 5. Clinical setting Patient scheduled for surgery at Medical Point Wiesbaden

Exclusion criteria

Exclusion criteria: 1. Cardiac arrhythmias Pre-existing arrhythmias such as atrial fibrillation or AV block (Grade II or III) 2. Cardiac devices Presence of a pacemaker 3. Medication – anticholinergic Preoperative use of parasympatholytic agents 4. Medication – sympathomimetic Preoperative use of sympathomimetic agents 5. Substance abuse Known drug abuse (especially narcotics)

Design outcomes

Primary

MeasureTime frame
Primary endpoints include changes in NOL® and qNOX® values in response to predefined nociceptive events.

Secondary

MeasureTime frame
Secondary endpoints comprise hemodynamic parameters (heart rate, mean arterial pressure), EEG-based depth of anesthesia (qCON®), as well as patient age and sex.

Countries

Germany

Contacts

Public ContactAlexander Ziebart

Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie

alexander.ziebart@unimedizin-mainz.de+496131-179817

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026