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The purpose of this study is to determine whether analgesia guided by pupillary reflex during laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and postoperative morphine).This is a prospective, randomized, controlled study performed in two centers.
For now, intraoperative analgesia remains hard to assess in the absence of reliable and validated analgesia monitor. The analysis of pupillary reflex is a new tool to assess analgesia during the intraoperative and postoperative period.
During laparoscopic surgery, carbon dioxide insufflation that produce pneumoperitoneum may induce hemodynamics events such as tachycardia or hypertension. These events may be misleading or confusing. Actually, these events are mainly considered as insufficient analgesia. Thus, anesthesiologists deepen analgesia and/or anesthesia by increasing concentration of anesthetics or opioids. These inappropriate actions may induce hypotension and/or bradycardia especially in elderly patients. On the contrary, insufficient analgesia may exist in hypovolemic patients or in patients with neuromuscular blocking agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pupillometry guided analgesia (PP) | Experimental | Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided. |
|
| Standard practice (ST) | No Intervention | Anesthesia and analgesia is left to the discretion of the anesthesiologist in charge. The anesthesiologist is blinded to the results of pupillometry. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pupillometry guided analgesia (PP) | Device | Analgesia is guided by pupillary reflex provided by the pupillometer (AlgiScan). The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed (Tailored remifentanil controlled infusion). Administration of antihypertensive drugs or vasopressors is also guided. |
| Measure | Description | Time Frame |
|---|---|---|
| Peroperative Remifentanil consumption | From the start of anesthesia to the end of surgery (<10 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...) | From the start of anesthesia to the end of surgery (<10 hours) | |
| Use of antihypertensive agents or vasopressors | From the start of anesthesia to the end of surgery (<10 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude MEISTELMAN, MD., PhD. | Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE | Study Chair |
| Philippe GUERCI, MD | Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE | Principal Investigator |
| Florence VIAL, MD | Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France | Principal Investigator |
| Hervé BOUAZIZ, MD., PhD. | Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternité Régionale Universitaire (MRU) | Nancy | Lorraine | 54000 | France | ||
| Centre Hospitalier Universitaire, Brabois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33913678 | Derived | Guerci P, Jay G, Arnout C, Herbain D, Baka N, Poirel O, Novy E, Bouaziz H, Vial F. Effects of pupillary reflex dilation-guided opioid administration on remifentanil and morphine consumption during laparoscopic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Sep 1;38(9):975-984. doi: 10.1097/EJA.0000000000001491. |
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|
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| Tailored remifentanil controlled infusion | Drug | The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed |
|
|
| Tailored antihypertensive drug administration | Drug | Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex. |
|
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| Volume of fluid replacement | From the start of anesthesia to the end of surgery (<10 hours) |
| Pain scores | Using verbal rating scale | In the immediate postoperative period (<4 hours) |
| Incidence of postoperative nausea and vomiting (PONV) | In the immediate postoperative period (<4 hours) |
| Time from extubation between the end of surgery and PACU admission | In the immediate postoperative period (<4 hours) |
| Length of stay in PACU | From PACU admission to an ALDRETE score of 10 (< 4 hours) |
| Immediate postoperative morphine consumption | During postanesthetic care unit (PACU) stay (<4 hours) |
| Nancy |
| Lorraine |
| 54500 |
| France |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C036604 | esmolol |
| D009529 | Nicardipine |
| C015568 | urapidil |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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