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

University Hospital Schleswig-Holstein60 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Pain Stress Monitoring

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany

Outcomes

Primary Outcomes

ANI vs. SPI

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).

Time frame: Data will be assessed and collected immediately after completion of each case of surgery.

Data from ClinicalTrials.gov

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