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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain; Stress; Monitoring

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • University Hospital Schleswig-Holstein, Campus Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total number of 45 patients ≥ 18 years with a body mass index (BMI) < 35 kg m-2 and an American Society of Anesthesiologists (ASA) status I-III scheduled for elective urology and gynaecology surgery in lithotomy position were randomized. Additionally, 15 volunteers served as a control group under no anaesthesia.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
General Anaesthesia; ANI and SPI values under general anaesthesia
Spinal Anaesthesia; ANI and SPI values under spinal anaesthesia
Spinal Anaesthesia + Sedation; ANI and SPI values under spinal anesthesia in combination with sedation
Control; ANI and SPI values under no anaesthesia

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Principal Investigator: Matthias Grünewald, MD, Department of Anaesthesiology and Intensive Care Medicine

Publications and helpful links

General Publications

• Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.
• Ilies C, Ludwigs J, Gruenewald M, Thee C, Hanf J, Hanss R, Steinfath M, Bein B. The effect of posture and anaesthetic technique on the surgical pleth index. Anaesthesia. 2012 May;67(5):508-513. doi: 10.1111/j.1365-2044.2011.07051.x. Epub 2012 Feb 11.
• Boselli E, Daniela-Ionescu M, Begou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (ESTIMATE): April 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: ANI_SPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO