Skip to main content
OpenTrials
Completed

NCT Number: NCT03103698

The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

About this study

The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice. Currently, this assessment is based on hemodynamic changes, although hypertension or tachycardia is neither sensitive nor specific. An overdose in opioids exposes to many side effects ranging from respiratory depression to phenomena of post-operative hyperalgesia. Conversely, an under-dosage in opioids is at the origin of a nociceptive stress whose neurovegetative and hormonal response can aggravate post-operative morbidity or promote the occurrence of implicit memorization.

Nociceptive influx can not be detected directly. However, its ascent to the somesthetic area of the cerebral cortex leads to physiological reactions that can be evaluated. In particular, there are numerous anatomical and functional interactions between the autonomic nervous system and the nociceptive tract in the brain stem. These interactions are mainly at the level of the gray periqueducal substance, the rostral ventro-lateral bulbous region, the solitary tract nucleus and the hypothalamus. The nociceptive influx thus leads to changes in the activity of the ANS. The study of changes in the ANS would therefore be a method of assessing the intensity of the nociceptive influx.

This objective method can be used in the non-communicating or unconscious patient to evaluate the pain and to adapt the analgesic treatment to the best.

Obese patients who receive surgical management often have comorbidities such as restrictive syndrome, or obstructive sleep apnea syndrome. They thus represent a target of choice in perioperative analgesic optimization in order to avoid respiratory complications that may be related to over or under assay of morphine such as atelectasis, alveolar hypoventilation.

It is hypothesized that this device is more effective for the intraoperative evaluation of analgesia than the usual method based on hemodynamic changes in intraoperatively anesthetized patients for bariatric surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

To demonstrate the monitoring of perioperative analgesia

Device

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

Standard preoperative evaluation of analgesia

Other

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

Primary outcomes

  1. The amount of morphine used per operatively in the two groups

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery: a Randomized Single Blind Study.

Acronym: ANI

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.