Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT05887258
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2023-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2023-04-16', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'intraoperative Security', 'timeFrame': '1 day', 'description': 'Presentation of complications during the surgical intervention defined as a situation that requires immediate action by the anesthetist and lasts more than 30 minutes, the interruption of the operation and/or conversion to open surgery.'}, {'measure': 'postoperative security', 'timeFrame': '3 day', 'description': 'Operative hypoxemia defined as oxygen saturation by pulseoximetry less than 90% Incidence of Postoperative Nausea and Vomiting (PONV) during de first 3 days Postoperative ileus defined as the absence of bowel movements during the first 3 days'}], 'primaryOutcomes': [{'measure': 'Pain control', 'timeFrame': '3 days', 'description': 'milligrams of opioids required postoperatively during the first 3 of admission'}], 'secondaryOutcomes': [{'measure': 'VNS score', 'timeFrame': '3 days', 'description': 'Pain measured through the visual analogue scale (VAS) during the first 3 days of admission'}, {'measure': 'morphine rescues', 'timeFrame': '7 days', 'description': 'Number of opiate rescues required during the postoperative period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare opioid free anesthesia versus opioid anesthesia in patients undergo laparoscopic colorectal surgery. The main question it aims to answer is assess the efficacy of opioid-free anaesthesia respect to postoperative pain control in patients undergoing a laparoscopic colorectal surgery.\n\nParticipants will answer a questionnaire during the first 3 days of admission, assessing pain through the visual analog scale (VAS).\n\nThe researchers will compare the consumption of opiates during the postoperative period in the opioid-free anesthesia group.', 'detailedDescription': 'The objective of the study is to know the efficacy of OFA in laparoscopic colorectal surgery. The consumption of opiates will be evaluated according to the VAS scale, defining non-tolerable pain greater than 5. The number of rescues required, the time elapsed until the first rescue and the total consumption of opiates administered will be evaluated.\n\nOther variables that will be evaluated will be safety variables defined as intraoperative complications that require immediate action by the anesthesiologist, interruption of the procedure, or conversion to open surgery.\n\nOther variables evaluated will be postoperative complications:\n\n* Postoperative hypoxemia.\n* Incidence of postoperative nausea and vomiting (PONV).\n* Postoperative ileus.\n* surgical complications.\n* medical complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n( - ) Patients older than or equal to 18 years.\n\n(-) Patients scheduled for laparoscopic colorectal surgery.\n\n(-) Patients with physical status classification (ASA) I-III.\n\n(- ) Patients who have signed the informed consent of the clinical trial\n\nExclusion Criteria:\n\n(-) Pregnant or lactating patients.\n\n(-)Patients with allergy to any of the drugs or excipients used in the study\n\n(-) Emergency laparoscopic colorectal surgery\n\n(-) Patients with AV block, intraventricular block, or sinus block\n\n(-) Adam-Stokes syndrome.\n\n(-) Patient on chronic beta-blocker treatment with HR \\< 50 bpm\n\n(-) Patient with ejection fraction \\< 40% known\n\n(-) Epilepsy.\n\n(-) Surgery converted to open surgery\n\n(-) Legally disabled patient\n\n(-) Patients with physical status classification (ASA) IV.'}, 'identificationModule': {'nctId': 'NCT05887258', 'acronym': 'OFA_GAL_21', 'briefTitle': 'Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Osakidetza'}, 'officialTitle': 'Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery', 'orgStudyIdInfo': {'id': '2021-003245-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opioid free anesthesia (OFA)', 'description': 'This arm is administered by the anesthesiologist in charge of the operating room.\n\nIt is composed by Dexmedetomidine (Dexdor), Lidocaine, Magnesium Sulfate and ketamine (Ketolar).', 'interventionNames': ['Drug: Opioid free anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid based Anesthesia (OA)', 'description': 'This arm is administered by the anesthesiologist in charge of the operating room.\n\nThis arm is composed of Remifentanil hydrochloride and postoperative rescue analgesia will be morphine.', 'interventionNames': ['Drug: Opioid based Anesthesia']}], 'interventions': [{'name': 'Opioid free anesthesia', 'type': 'DRUG', 'otherNames': ['OFA'], 'description': "It administers a combination of drugs to replace the opioid derivatives. Among them, we will use lidocaine, ketamine, dexmetomidine, and magnesium sulfate in continuous infusion adjusted to the patient's weight during surgery.", 'armGroupLabels': ['Opioid free anesthesia (OFA)']}, {'name': 'Opioid based Anesthesia', 'type': 'DRUG', 'otherNames': ['Traditional anesthesia'], 'description': 'administer anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention.', 'armGroupLabels': ['Opioid based Anesthesia (OA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48960', 'city': 'Galdakao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Galdakao', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}], 'overallOfficials': [{'name': 'Unai Ortega, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osakidetza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unai Ortega Mera', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osakidetza', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Unai Ortega Mera', 'investigatorAffiliation': 'Osakidetza'}}}}