NCT03103698

Brief Summary

The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Oct 2016

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

Study Start

First participant enrolled

October 17, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

March 31, 2017

Last Update Submit

November 17, 2025

Conditions

SurgeryObese

Keywords

analgesia per-operative

Outcome Measures

Primary Outcomes (1)

  • The amount of morphine used per operatively in the two groups

    1 day

Study Arms (2)

Monitoring of perioperative analgesia by the ANI device

OTHER
Device: To demonstrate the monitoring of perioperative analgesia

conventional monitoring based on hemodynamic variations.

OTHER
Other: Standard preoperative evaluation of analgesia

Interventions

To demonstrate the monitoring of perioperative analgesiaDEVICE

To demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations.

Monitoring of perioperative analgesia by the ANI device
Standard preoperative evaluation of analgesiaOTHER

To demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations.

conventional monitoring based on hemodynamic variations.

Eligibility Criteria

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

You may qualify if:

  • Major Patient Age ≥ 18 years
  • Adult patients candidate for planned surgery with BMI\> 30.
  • Affiliation to social security.
  • Patients who were clearly informed and signed consent.

You may not qualify if:

  • Patient with a heart rhythm disorder.
  • Respiratory rate less than 9 cycles / min.
  • Irregular spontaneous ventilation.
  • Perioperative use of a drug acting on the sinus node (eg atropine, etc.)
  • History of neuropathic pain.
  • Patient under morphine until the day before surgery.
  • Patients under guardianship or curatorship or deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

October 17, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

FR(1)