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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia And The Effect Of Posture. A Prospective Randomized Controlled Trial.

Conditions
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Pain, Stress, Monitoring

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General Anaesthesia<br>ANI and SPI values under general anaesthesia | |
| Spinal Anaesthesia<br>ANI and SPI values under spinal anaesthesia | |
| Spinal Anaesthesia + Sedation<br>ANI and SPI values under spinal anesthesia in combination with sedation | |
| Control<br>ANI and SPI values under no anaesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Data will be assessed and collected immediately after completion of each case of surgery. |