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

NCT ID: NCT03864016

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2019-10-22

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.

Conditions

Patients Undergoing Cardiac Surgery; Patients With Coronary Artery Bypass Surgery With CEC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Standard group

Group Type: OTHER

Induction and maintenance of anesthesia

Intervention Type: DRUG

The hypnotic agent used is Propofol and the morphine agent used is Sufentanil.

Adaptation of sufentanil doses according to the usual protocol

Intervention Type: DRUG

At induction the target concentration of sufentanil is 0.5 ng/ml. The sufentanil dose is decided by the anaesthetist, taking into account the operating times (induction, TIO, incision, opening and sternal spacing, CEC, closure), the usual data provided by the monitoring: heart rate, blood pressure, BIS, EtCO2, modification of insufflation pressures.

Pupillometry group

Group Type: EXPERIMENTAL

Induction and maintenance of anesthesia

Intervention Type: DRUG

The hypnotic agent used is Propofol and the morphine agent used is Sufentanil.

Adjustment of sufentanil doses according to pupillometry

Intervention Type: DRUG

At induction, the target concentration of sufentanil is 0.5 ng/ml. The dose of sufentanil is then adjusted according to the dilation reflex obtained with the PPI (Pain Pupillary Index) at predefined times.

Interventions

Induction and maintenance of anesthesia

The hypnotic agent used is Propofol and the morphine agent used is Sufentanil.

Intervention Type: DRUG

Adaptation of sufentanil doses according to the usual protocol

At induction the target concentration of sufentanil is 0.5 ng/ml. The sufentanil dose is decided by the anaesthetist, taking into account the operating times (induction, TIO, incision, opening and sternal spacing, CEC, closure), the usual data provided by the monitoring: heart rate, blood pressure, BIS, EtCO2, modification of insufflation pressures.

Intervention Type: DRUG

Adjustment of sufentanil doses according to pupillometry

At induction, the target concentration of sufentanil is 0.5 ng/ml. The dose of sufentanil is then adjusted according to the dilation reflex obtained with the PPI (Pain Pupillary Index) at predefined times.

Intervention Type: DRUG

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.
• ASA <4.

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,
• Refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Countries

France

References

Berthoud V, Nguyen M, Appriou A, Ellouze O, Radhouani M, Constandache T, Grosjean S, Durand B, Gounot I, Bahr PA, Martin A, Nowobilski N, Bouhemad B, Guinot PG. Pupillometry pain index decreases intraoperative sufentanyl administration in cardiac surgery: a prospective randomized study. Sci Rep. 2020 Dec 3;10(1):21056. doi: 10.1038/s41598-020-78221-5.

Reference Type: DERIVED

PMID: 33273644 (View on PubMed)

Other Identifiers

BERTHOUD 2018

Identifier Type: -

Identifier Source: org_study_id