NCT02193412

Brief Summary

The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 4, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
Last Updated

April 22, 2026

Status Verified

October 1, 2020

Enrollment Period

2.7 years

First QC Date

July 15, 2014

Last Update Submit

April 17, 2026

Conditions

HypovolemiaSomatic Pain

Keywords

analgesia nociception indexheart rate variabilityautonomic nervous systemspecificitysystemic venous returnpulse pressure variationIntraoperative Monitoring

Outcome Measures

Primary Outcomes (1)

  • change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position

    Position -20° to +20°

    during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

Secondary Outcomes (5)

  • change in ANI between horizontal position and head-down/head up tilt position

    during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

  • change in pulse pressure variation between head-down tilt position and head-up tilt position

    during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

  • change in ANI induced by standardized noxious stimulus (tetanic stimulation)

    during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)

  • variations of low frequency variability of arterial blood pressure

    during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

  • change in pulse pressure variation between horizontal position and head-down/head up tilt position

    during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

Study Arms (1)

patients

EXPERIMENTAL

1. noxious stimulus 2. change in operating table slope: head-down tilt position 3. change in operating table slope: head-up tilt position

Procedure: noxious stimulusProcedure: change in operating table slope: head-down tilt positionProcedure: change in operating table slope: head-up tilt position

Interventions

noxious stimulusPROCEDURE

standardized noxious stimulus with tetanic stimulation

patients
change in operating table slope: head-down tilt positionPROCEDURE

-30°

Also known as: Trendelenburg position
patients
change in operating table slope: head-up tilt positionPROCEDURE

+30°

patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • neurosurgical operation requiring invasive monitoring of arterial blood pressure

You may not qualify if:

  • pacemaker, arrhythmia
  • chronic medication with beta blocker
  • possible disorder of autonomic nervous system: diabetes, alcoholism, chronic pain
  • anticholinergic drug administration before measures
  • intracranial hypertension
  • no social security coverage
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Lille, Nord, 59000, France

Location

Related Publications (1)

  • Lamer A, Jeanne M, Marcilly R, Kipnis E, Schiro J, Logier R, Tavernier B. Methodology to automatically detect abnormal values of vital parameters in anesthesia time-series: Proposal for an adaptable algorithm. Comput Methods Programs Biomed. 2016 Jun;129:160-71. doi: 10.1016/j.cmpb.2016.01.004. Epub 2016 Jan 14.

    PMID: 26817405RESULT

MeSH Terms

Conditions

HypovolemiaNociceptive Pain

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Benoît Tavernier, Pr

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

  • Délégation à la Recherche Clinique et à l'Innovation (DRC)

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Study Start

January 4, 2015

Primary Completion

October 3, 2017

Study Completion

October 3, 2017

Last Updated

April 22, 2026

Record last verified: 2020-10

Locations

FR(1)