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

Surgery Clinical Trial

— ANI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103698
• Other study ID #: PI2015_843_0032
• Status: Completed
• Phase: N/A
• Start date: October 17, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obese
• Surgery

Intervention

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

Other:
• Standard preoperative evaluation of analgesia
To demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of morphine used per operatively in the two groups		1 day