Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)

NCT01633320 | Completed Results DMC

• 1 other identifier: CPP 2012-021 B
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.

Conditions

Postoperative Pain

Keywords

Analgesia/Nociception index

Outcome Measures

Primary Outcomes (2)

• Analgesia/Nociception Index (ANI)

  The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.

  At arrival in post-operative care unit (PACU) or 10 min after extubation

• Pain Scores on a 0-10 Numeric Rating Scale (NRS)

  Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS\<3 corresponds to no or mild pain NRS\>=3 corresponds to moderate to severe pain NRS\>=7 corresponds to severe pain

  At arrival in PACU or 10 min after extubation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients underoing surgical or endoscopic procedures performed on general anesthesia

You may qualify if:

• adult
• surgical or endoscopic procedures performed on general anesthesia

You may not qualify if:

• age \<18 yrs or \>75 yrs
• arrythmia
• administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
• psychiatric diseases
• autonomic nervous system (ANS) disorders
• inability to understand the verbal rating pain scale.

Sponsors & Collaborators

• Hôpital Edouard Herriot: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL

Lyon, 69003, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Dr Emmanuel Boselli
• Organization: Edouard Herriot hôspital Anaesthesia and intensive care

emmanuel.boselli@chu-lyon.fr

+334711689

Study Officials

• Lionel Bouvet, MD

  Édouard Herriot hospital, HCL

  PRINCIPAL INVESTIGATOR

• Gérard Bégou, MD

  Édouard Herriot hospital, HCL

  PRINCIPAL INVESTIGATOR

• Rabia Dabouz, MD

  Édouard Herriot hospital, HCL

  PRINCIPAL INVESTIGATOR

• Christophe Magnin, MD

  Édouard Herriot hospital, HCL

  PRINCIPAL INVESTIGATOR

• Bernard Allaouchiche, MD, PhD

  Édouard Herriot hospital, HCL

  STUDY CHAIR

• Emmanuel Boselli, MD, PhD

  Édouard Herriot hospital, HCL

  STUDY DIRECTOR

• Mirela-Daniela Ionescu, MD

  Édouard Herriot hospital, HCL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 4, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 18, 2012
• Results First Posted: December 18, 2012

Record last verified: 2012-11

Locations

FR (1)