Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-05 @ 7:05 PM
Study NCT ID:
NCT04462094
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2020-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only care providers involved directly with the subjects in the operating room are not masked.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a double-blind, randomized control trial. It provides a controlled care comparison between low-dose ketamine given at anesthesia induction and at the end-of-surgery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum CRP level', 'timeFrame': '1-hour before surgery', 'description': 'Serum C-reactive protein level'}, {'measure': 'Serum CRP level', 'timeFrame': '24-hours after surgery', 'description': 'Serum C-reactive protein level'}, {'measure': 'serum neutrophil-count', 'timeFrame': '1-hour before surgery', 'description': 'serum neutrophil-count (from a complete blood count test)'}, {'measure': 'serum neutrophil-count', 'timeFrame': '24-hours after surgery', 'description': 'serum neutrophil-count (from a complete blood count test)'}, {'measure': 'VAS (visual analog score)', 'timeFrame': 'first 24 hours after the surgery', 'description': 'minimum=0; maximum=10; higher score corresponds to more severe pain'}, {'measure': 'morphine consumption (mg)', 'timeFrame': 'first 24 hours after the surgery', 'description': 'total morphine consumption in 24 hours after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress response', 'infammation', 'general anesthesia'], 'conditions': ['General Anesthesia', 'Laparotomy', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.', 'detailedDescription': 'The effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.\n\nThe acute analgesic effect of ketamine is generally believed to be mediated through the blockade of the phencyclidine binding site of the N-methyl-d-aspartate (NMDA) receptor of nociceptive neurons. Ketamine can reduce the inflammatory response marked by a decrease in CRP levels to surgical trauma and can prevent secondary damage to tissues/organs that were not initially affected by surgery by reducing inflammation. This also reduces postoperative pain and analgesics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing elective laparotomy with general anesthesia at Sanglah Hospital from July to September 2020.\n2. Patients aged 18-65 years.\n3. Patient physical status American American Society of Anesthesiologist (ASA) 1 and 2.\n\nExclusion Criteria:\n\n1. Contraindication to ketamine.\n2. Allergy to morphine\n3. Presence of cardiorespiratory chronic diseases.\n4. Presence of autoimmune diseases.\n5. History of the central nervous system or psychiatric disorders.\n6. BMI \\<18.5 kg/m2 or ≥30 kg/m2.\n7. A history of chronic pain killer medications (such as opioid or non-steroidal anti- inflammatory drugs)\n\nDrop Out Criteria\n\n1. Patients with class 3 bleeding during the surgery\n2. Patients with more than 5-hours duration of surgery\n3. Patients need mechanical ventilation after the surgery'}, 'identificationModule': {'nctId': 'NCT04462094', 'acronym': 'PRO-Ketamine', 'briefTitle': 'Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy', 'organization': {'class': 'OTHER', 'fullName': 'Udayana University'}, 'officialTitle': 'Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy', 'orgStudyIdInfo': {'id': 'UNUD-CTR-FK260620-002'}, 'secondaryIdInfos': [{'id': '1143/UN14.2.2.VII.14/LT/2020', 'type': 'OTHER', 'domain': 'Committee of Ethical Research of Udayana University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'End-of-surgery', 'description': 'Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery', 'interventionNames': ['Drug: Ketamine 0.3 mg/kg at end-of-surgery', 'Drug: Ketamine 0.3 mg/kg at anesthesia induction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Induction', 'description': 'Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction', 'interventionNames': ['Drug: Ketamine 0.3 mg/kg at end-of-surgery', 'Drug: Ketamine 0.3 mg/kg at anesthesia induction']}], 'interventions': [{'name': 'Ketamine 0.3 mg/kg at end-of-surgery', 'type': 'DRUG', 'otherNames': ['Group E'], 'description': 'Ketamine 0.3 mg/kg at end-of-surgery (intravenously)', 'armGroupLabels': ['End-of-surgery', 'Induction']}, {'name': 'Ketamine 0.3 mg/kg at anesthesia induction', 'type': 'DRUG', 'otherNames': ['Group I'], 'description': 'Ketamine 0.3 mg/kg at anesthesia induction (intravenously)', 'armGroupLabels': ['End-of-surgery', 'Induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80114', 'city': 'Denpasar', 'state': 'Bali', 'country': 'Indonesia', 'facility': 'Sanglah General Hospital', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}], 'overallOfficials': [{'name': 'Tjokorda GA Senapathi, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Udayana University'}, {'name': 'Christopher Ryalino, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Udayana University'}, {'name': 'Made SP Adi, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Udayana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Udayana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher Ryalino', 'investigatorAffiliation': 'Udayana University'}}}}