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

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Pain; Monitoring; Stress

Study type: Observational

Funder types: Other

Identifiers

NCT02744573

ANI_SPI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

General Anaesthesia

Description:

ANI and SPI values under general anaesthesia

Spinal Anaesthesia

Description:

ANI and SPI values under spinal anaesthesia

Spinal Anaesthesia + Sedation

Description:

ANI and SPI values under spinal anesthesia in combination with sedation

Control

Description:

ANI and SPI values under no anaesthesia