Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia

Completed

• Conditions: Stress; Pain; Monitoring

• Registration Number: NCT02744573
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia.

Detailed Description

While sophisticated haemodynamic monitoring as well as depth of neuromuscular block and sedation are established in daily clinical routine monitoring of analgesia remains poorly represented. The surgical pleth index (SPI) algorithm takes into account both central and peripheral sympathetic tone via the normalised heart beat interval and the plethysmographic pulse wave amplitude and has been described before. A more detailed investigation on the SPI and its behaviour under a posture maneuver shows the limitation of the device.

Another device developed calculates the "analgesia nociception index" (ANI) by heart rate variability and was launched into the market in 2010. However, the effect of posture - to our knowledge - has not yet been studied. The change of body positioning during surgery is regularly necessary in order to improve surgical access to anatomic structures. These alterations in positioning are known to be accompanied by changes in haemodynamic parameters.

The aim of this study was to evaluate the ANI in patients undergoing elective surgery in lithotomy position.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-12-14
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-15
• Last Update Submitted: 2016-04-15
• Study First Posted: 2016-04-20
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ≥ 18 years
• Body mass index (BMI) < 35 kg m2
• American Society of Anesthesiologists (ASA) status I-III
• Elective urology and gynaecology surgery in lithotomy position
• 15 healthy volunteers were included in the study as a control group

Exclusion Criteria

• Age < 18 years
• ASA status IV or higher
• BMI ≥ 35 kg m2
• Chronic heart rhythm disorders
• Implanted pacemakers
• Patients with a history of chronic pain and emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ANI vs. SPI	Data will be assessed and collected immediately after completion of each case of surgery.	Evaluation of the ANI and comparison to SPI (same unit of measure, both ranging between 0-100, no dimension) in patients undergoing elective surgery in lithotomy position. Evaluation and change of ANI and SPI values at pre-defined timepoints: 1) Baseline, 2) before induction of anaesthesia, during 3) intubation or spinal punction, 4) posture maneuver, 5) skin incision 6) surgical suture, 7) post anesthetic care unit stay (arrival).

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany