Structured retrospective recording of quality assurance measures of the nociception level index (NOL) during surgical interventions

• Conditions: R52; Pain, not elsewhere classified

• Registration Number: DRKS00029120
• Lead Sponsor: Klinik für AnästhesiologieUniversitätsmedizin Mainz

Brief Summary

Nociceptive monitoring using the NOL® system during intracerebral and abdominal surgery is feasible and might yield helpful information to support therapeutic decisions. This could help to reduce hyperanalgesia, facilitating shorter emergence periods and less postoperative complications. Prospective clinical studies are needed to further examine the potential benefits of this monitoring approach in a neurosurgical context.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study Completion: 2023-12-31
• Results First Posted: 2024-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Age at least 18 years
- elective surgery
- Regional or general anesthesia

Exclusion Criteria

- Pre-existing arrhythmias such as atrial fibrillation, AV block grade II and III
- Pacemaker therapy
- Preoperative medication with a parasympatholytic agent
- Preoperative medication with a sympathomimetic agent
- Drug abuse (narcotics)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to retrospectively record the change in NOL during routine positioning procedures (Trendelenburg, lithotomy, and lateral positioning) and required drug administration (e.g., Akrinor) during general or regional anesthesia.

Secondary Outcome Measures

Name	Time	Method
Secondary objective: The secondary objective is to assess the influence of surgically necessary measures such as the installation of a capnoperitoneum on the nociception index.