Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-31 @ 1:44 AM
Study NCT ID:
NCT05717361
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2023-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Sparing Anesthesia in Cervical Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-28', 'studyFirstSubmitDate': '2023-01-28', 'studyFirstSubmitQcDate': '2023-01-28', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score on arrival to Post-Anesthesia Care Unit (PACU)', 'timeFrame': 'immediately postoperatively]', 'description': 'pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}, {'measure': 'pain score at discharge from Post-Anesthesia Care Unit (PACU)', 'timeFrame': 'at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively', 'description': 'pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}, {'measure': 'pain score 3 hours postoperatively', 'timeFrame': '3 hours postoperatively', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}, {'measure': 'pain score 6 hours postoperatively', 'timeFrame': '6 hours postoperatively', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}, {'measure': 'pain score 24 hours postoperatively', 'timeFrame': '24 hours postoperatively', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}], 'secondaryOutcomes': [{'measure': 'sedation on arrival to Post-Anesthesia Care Unit', 'timeFrame': 'immediately postoperatively', 'description': 'sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain'}, {'measure': 'sedation at discharge from Post-Anesthesia Care (PACU) Unit', 'timeFrame': 'at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively', 'description': 'sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain'}, {'measure': 'time to first request for analgesia', 'timeFrame': 'during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively', 'description': 'the time for the first patient request for analgesia will be noted'}, {'measure': 'morphine consumption in Post-Anesthesia Care Unit (PACU)', 'timeFrame': 'immediately postoperatively', 'description': 'mg of morphine requested during patient PACU stay'}, {'measure': 'tramadol consumption in the first 48 hours', 'timeFrame': '48 hours postoperatively', 'description': 'patients will be followed for cumulative tramadol consumption for 48 hours postoperatively'}, {'measure': 'fentanyl requirement during surgery', 'timeFrame': 'intraoperatively', 'description': 'dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value'}, {'measure': 'satisfaction from postoperative analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Pain, Acute', 'Pain, Chronic', 'Pain, Nociceptive', 'Ketamine', 'Lidocaine', 'Analgesia', 'Analgesics', 'Cervical Spine Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of lidocaine and ketamine in the same syringe versus remifentanyl analgesia in cervical spine surgery.', 'detailedDescription': 'Cervical spine surgery is associated with medium pain scores and perioperative disability. Ketamine and lidocaine have all proven but varied analgesic effects. High opioid consumption has been associated with multiple side effects.\n\nThis double blind clinical trial aims to investigate the possible reduction of opioid use during lumbar spine surgery by administering ketamine and lidocaine. Sixty patients will be randomly allocated into two groups. The control group will receive a continuous infusion of remifentanil, while the Ketamine-Lidocaine (KL) group will receive a continuous infusion of ketamine and lidocaine, during the surgery and shortly after.\n\nBoth infusions will be administered blindly. Fentanyl and morphine will be administered to each patient so as to maintain hemodynamic stability and pain relief. The study will eventually compare the need for bolus doses of fentanyl during the surgery and morphine shortly after in each group.\n\nMultiple hemodynamic parameters, analgesic consumption, possible side effects, patient satisfaction and the Oswestry low back pain disability questionnaire will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patents\n* American Society of Anesthesiologists (ASA) class I-III\n* elective spine surgery\n\nExclusion Criteria:\n\n* body mass index (BMI) \\>35 kg/m2\n* contraindications to local anesthetic administration\n* systematic use of analgesic agents preoperatively\n* chronic pain syndromes preoperatively\n* neurological or psychiatric disease on treatment\n* pregnancy\n* severe hepatic or renal disease\n* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities\n* bradycardia(\\<55 beats/minute)\n* drug or alcohol abuse\n* language or communication barriers lack of informed consent'}, 'identificationModule': {'nctId': 'NCT05717361', 'briefTitle': 'Opioid Sparing Anesthesia in Cervical Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Evangelismos Hospital'}, 'officialTitle': 'The Effect of a Regimen of Opioid Sparing Anesthesia on Postoperative Recovery', 'orgStudyIdInfo': {'id': '254/13-07-2022Β'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe', 'interventionNames': ['Drug: ketamine-lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': ': remifentanil group syringe of remifentanil', 'interventionNames': ['Drug: Remifentanil']}], 'interventions': [{'name': 'ketamine-lidocaine', 'type': 'DRUG', 'otherNames': ['KL group'], 'description': 'In the KL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine at predefined concentrations.\n\nAs maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution', 'armGroupLabels': ['ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe']}, {'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Remifentanil group'], 'description': 'In the Remifentanil group, patients will be administered in a total volume of 20 mL, 2 mcg/kg of fentanyl. As maintenance, they will be receiving 1 mL/10kg/h of a remifentanil solution', 'armGroupLabels': [': remifentanil group syringe of remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Athanasios Vaiopoulos', 'role': 'CONTACT'}, {'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Athanasios Vaiopoulos', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Evangelismos General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'CONTACT', 'email': 'ktheodoraki@hotmail.com', 'phone': '+306974634162'}, {'name': 'Athanasios Vaiopoulos', 'role': 'CONTACT', 'email': 'thanasisvaio@gmail.com'}], 'overallOfficials': [{'name': 'Kassiani Theodoraki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aretaieion University Hospital, Athens, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evangelismos Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aretaieion University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesia Resident', 'investigatorFullName': 'Athanasios Vaiopoulos', 'investigatorAffiliation': 'Evangelismos Hospital'}}}}