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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Pain Stress Monitoring

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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General Anaesthesia

ANI and SPI values under general anaesthesia

No interventions assigned to this group

Spinal Anaesthesia

ANI and SPI values under spinal anaesthesia

No interventions assigned to this group

Spinal Anaesthesia + Sedation

ANI and SPI values under spinal anesthesia in combination with sedation

No interventions assigned to this group

Control

ANI and SPI values under no anaesthesia

No interventions assigned to this group

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes