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

NCT02744573 | Completed

• 1 other identifier: ANI_SPI
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Stress; Monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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
• healthy volunteers were included in the study as a control group

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (3)

• 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.

  PMID: 17329347 BACKGROUND

• 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.

  PMID: 22324319 BACKGROUND

• 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.

  PMID: 23592690 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Grünewald, MD

  Department of Anaesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: April 20, 2016
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 20, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)