NCT03568396

Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The relationship between the target effect site concentration of remifentanil and the pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extra corporeal circulation will be evaluated.

Detailed description

Anaesthesia will be induced with propofol to obtain loss of consciousness LOC in 30 patients who will undergo cardiac surgery requiring extracorporeal circulation and standardized support will be given to them till the extracorporeal circulation period. Thereafter, remifentanil will be titrated by increments of 0,5, from 1 up to 5 ng ml-1 during the extra corporeal circulation period. In the awake state, at LOC and at each plateau level of remifentanil CeT, mean arterial pressure, and BIS will be recorded. Pupil size and dilatation after a 60 mA, 100 Hz tetanic stimulation will be measured at LOC and at each plateau level of remifentanil.

Conditions

• Pupil
• Analgesics
• Opioid Use
• Dose-Response Relationship, Drug
• Anesthetics, Intravenous
• Surgery, Cardiac
• Circulation, Extracorporeal
• Electric Stimulation
• Electroencephalography/Drug Effects
• Monitoring, Intraoperative
• Adult
• Remifentanil

Interventions

Type	Name	Description
DEVICE	Pupillometer	Measurement of pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extracorporeal circulation period.

Timeline

• Start date: 2018-08-22
• Primary completion: 2018-10-25
• Completion: 2018-10-25
• First posted: 2018-06-26
• Last updated: 2019-02-27

Locations

1 site across 1 country: France