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Clinical Trials/NCT03864016
NCT03864016
Completed
Not Applicable

Ability of Pupillometry to Reduce Sufentanil Consumption in Planned Cardiac Surgery: Randomized, Controlled, Single-center Clinical Superiority Trial

Centre Hospitalier Universitaire Dijon1 site in 1 country50 target enrollmentMarch 20, 2019

Overview

Phase
Not Applicable
Intervention
Induction and maintenance of anesthesia
Conditions
Patients Undergoing Cardiac Surgery
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
50
Locations
1
Primary Endpoint
Total dose of sufentanil required per operation
Status
Completed
Last Updated
2 months ago

Overview

Brief Summary

The objective of general anesthesia is to obtain a loss of consciousness, stillness, and sufficient analgesia to allow surgery. Thus, general anesthesia has two components: hypnosis and analgesia. Combining these two components, with parallel use of a hypnotic agent and a morphine agent makes major surgery possible by limiting the stress on the body. In clinical practice, hypnosis can be assessed by a monitor of the depth of BIS®-type anesthesia, based on a simplified measurement of the patient's spontaneous cortical electroencephalographic activity. However, BIS® type monitors do not specifically judge analgesia.

Traditionally, analgesia is assessed on the basis of hemodynamic changes (blood pressure, heart rate) in relation to a nociceptive stimulus. There is an interaction between pain and cardiovascular control that is mediated by the baroreflex system. But not all hemodynamic changes during general anesthesia are necessarily secondary to nociceptive stimulation. For example, hypovolemia may be responsible for tachycardia without causing pain; opening the pericardium during cardiac surgery may increase blood pressure by increasing cardiac output.... On the other hand, a decrease in hemodynamic response can be observed in relation to the depressant effect of anesthetic agents, despite a lack of analgesia. Similarly, patients' disease-modifying treatments may mask hemodynamic responses (e.g. beta blocker). Thus, the appearance of tachycardia or high blood pressure during surgery does not necessarily reflect a nociceptive process. Currently, the available data do not allow the anaesthetist to differentiate between real hemodynamic changes related to nociception and sympathicotonia. This leads to typical management consisting of an increase in the dosage of morphine.

Pupillometry (monitoring the pupillary dilation reflex) is a simple and sensitive clinical approach that can be done during general anesthesia to specifically monitor the nociceptive component. The main objective of monitoring is to achieve a more rational use of opioids. This means optimizing opioid dosing, ensuring safety by monitoring the lowering of opioid dosages intraoperatively without the risk of waking up, and reducing postoperative hyperalgesia. In the context of cardiac surgery, the interpretation of hemodynamic changes could be facilitated by nociception monitoring coupled with anesthesia monitoring (BIS). Reducing opiod doses without changing other clinical parameters could ensure better hemodynamic stability in increasingly fragile patients.

Registry
clinicaltrials.gov
Start Date
March 20, 2019
End Date
October 22, 2019
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Person who has given written consent
  • Adult patient
  • Patient undergoing coronary artery bypass surgery with CEC, with or without valve surgery, by sternotomy.

Exclusion Criteria

  • Person not affiliated to the national health insurance system
  • Person subject to legal protection (curatorship, guardianship)
  • Person who has been deemed mentally incompetent
  • Pregnant, parturient or breastfeeding woman
  • Adult unable or unwilling to provide consent
  • Patient with preoperative cognitive dysfunction (MMS \<13) (APPENDIX 6),
  • Patient with morphine intolerance,
  • Patient on long-term opioid treatment,
  • Emergency surgery,
  • Eye disease, corneal injury, or wearing contact lenses, a neurological disease that can influence the pupillary reflex,

Arms & Interventions

Standard group

Intervention: Induction and maintenance of anesthesia

Standard group

Intervention: Adaptation of sufentanil doses according to the usual protocol

Pupillometry group

Intervention: Induction and maintenance of anesthesia

Pupillometry group

Intervention: Adjustment of sufentanil doses according to pupillometry

Outcomes

Primary Outcomes

Total dose of sufentanil required per operation

Time Frame: Through study completion an average of 2 years

Total dose of sufentanil expressed in µg

Study Sites (1)

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