Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-27 @ 7:40 PM
Study NCT ID:
NCT02116868
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C036604', 'term': 'esmolol'}, {'id': 'D009529', 'term': 'Nicardipine'}, {'id': 'C015568', 'term': 'urapidil'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peroperative Remifentanil consumption', 'timeFrame': 'From the start of anesthesia to the end of surgery (<10 hours)'}], 'secondaryOutcomes': [{'measure': 'Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)', 'timeFrame': 'From the start of anesthesia to the end of surgery (<10 hours)'}, {'measure': 'Use of antihypertensive agents or vasopressors', 'timeFrame': 'From the start of anesthesia to the end of surgery (<10 hours)'}, {'measure': 'Volume of fluid replacement', 'timeFrame': 'From the start of anesthesia to the end of surgery (<10 hours)'}, {'measure': 'Pain scores', 'timeFrame': 'In the immediate postoperative period (<4 hours)', 'description': 'Using verbal rating scale'}, {'measure': 'Incidence of postoperative nausea and vomiting (PONV)', 'timeFrame': 'In the immediate postoperative period (<4 hours)'}, {'measure': 'Time from extubation between the end of surgery and PACU admission', 'timeFrame': 'In the immediate postoperative period (<4 hours)'}, {'measure': 'Length of stay in PACU', 'timeFrame': 'From PACU admission to an ALDRETE score of 10 (< 4 hours)'}, {'measure': 'Immediate postoperative morphine consumption', 'timeFrame': 'During postanesthetic care unit (PACU) stay (<4 hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pupillometry', 'Pupillary reflex', 'Analgesia', 'Laparoscopic surgery', 'Total intravenous anesthesia', 'Target controlled infusion'], 'conditions': ['Scheduled Laparoscopic Surgery']}, 'referencesModule': {'references': [{'pmid': '33913678', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists status 1 to 4\n* Scheduled laparoscopic surgery\n* Standardized anesthesia (TCI)\n* Social security affiliation\n\nExclusion Criteria:\n\n* Age \\< 18 yrs old\n* Emergency\n* BMI ≥ 35 kg.m-2\n* Refusal of consent\n* History of ocular pathology\n* Intake of: metoclopramide, droperidol, opioids or substitutive therapies\n* Patient with chronic pain\n* Neurologic impairments\n* Neuropathic pain\n* Drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT02116868', 'briefTitle': 'Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.', 'orgStudyIdInfo': {'id': '2013-A01002-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pupillometry guided analgesia (PP)', 'description': '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.', 'interventionNames': ['Device: Pupillometry guided analgesia (PP)', 'Drug: Tailored remifentanil controlled infusion', 'Drug: Tailored antihypertensive drug administration']}, {'type': 'NO_INTERVENTION', 'label': 'Standard practice (ST)', 'description': 'Anesthesia and analgesia is left to the discretion of the anesthesiologist in charge. The anesthesiologist is blinded to the results of pupillometry.'}], 'interventions': [{'name': 'Pupillometry guided analgesia (PP)', 'type': 'DEVICE', 'otherNames': ['Algiscan Neurolight', 'Pupillometer'], 'description': '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.', 'armGroupLabels': ['Pupillometry guided analgesia (PP)']}, {'name': 'Tailored remifentanil controlled infusion', 'type': 'DRUG', 'otherNames': ['Traget controlled infusion', 'TCI'], 'description': 'The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed', 'armGroupLabels': ['Pupillometry guided analgesia (PP)']}, {'name': 'Tailored antihypertensive drug administration', 'type': 'DRUG', 'otherNames': ['Esmolol', 'Nicardipine', 'Urapidil'], 'description': 'Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.', 'armGroupLabels': ['Pupillometry guided analgesia (PP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': 'Maternité Régionale Universitaire (MRU)', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '54500', 'city': 'Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire, Brabois', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Claude MEISTELMAN, MD., PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE'}, {'name': 'Philippe GUERCI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE'}, {'name': 'Florence VIAL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France'}, {'name': 'Hervé BOUAZIZ, MD., PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}