Clinical trial NCT02744573: Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Stress
Monitoring
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: ANI vs. SPI
timeFrame: Data will be assessed and collected immediately after completion of each case of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care Medicine
name: Matthias Grünewald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.