Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-04-24 @ 12:25 AM
Study NCT ID:
NCT02569905
Status:
COMPLETED
Last Update Posted:
2015-10-27
First Post:
2015-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Parecoxib Sodium and Flurbiprofen Injection on Postoperative Shivering
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C409945', 'term': 'parecoxib'}, {'id': 'D005480', 'term': 'Flurbiprofen'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-23', 'studyFirstSubmitDate': '2015-10-01', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shivering', 'timeFrame': 'in one hour after extubation.'}], 'secondaryOutcomes': [{'measure': 'visual analogue score', 'timeFrame': 'at the time of extubation, 30min and 60min after extubation.'}, {'measure': 'sedation scores', 'timeFrame': 'at the time of extubation, 30min and 60min after extubation.'}, {'measure': 'incidence of postoperative nausea and vomiting', 'timeFrame': 'in one hour after extubation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['flurbiprofen', 'Parecoxib sodium', 'Postoperative Shivering'], 'conditions': ['Postoperative Shivering']}, 'referencesModule': {'references': [{'pmid': '10844839', 'type': 'BACKGROUND', 'citation': 'Buggy DJ, Crossley AW. Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering. Br J Anaesth. 2000 May;84(5):615-28. doi: 10.1093/bja/84.5.615. No abstract available.'}, {'pmid': '26281342', 'type': 'BACKGROUND', 'citation': 'Kilbas Z, Mentes MO, Harlak A, Yigit T, Balkan SM, Cosar A, Ozturk E, Kozak O, Tufan CT. Efficacy of wound infiltration with lornoxicam for postoperative analgesia following thyroidectomy: a prospective, randomized, double-blind study. Turk J Med Sci. 2015;45(3):700-5. doi: 10.3906/sag-1402-125.'}, {'pmid': '26025794', 'type': 'BACKGROUND', 'citation': 'Yang X, Peng N, Li N, Li J. Effect of cyclooxygenase-2-specific inhibitors on postoperative analgesia after major open abdominal surgery. Pain Manag Nurs. 2015 Jun;16(3):242-8. doi: 10.1016/j.pmn.2014.07.004.'}, {'pmid': '26345202', 'type': 'BACKGROUND', 'citation': 'Ayrian E, Kaye AD, Varner CL, Guerra C, Vadivelu N, Urman RD, Zelman V, Lumb PD, Rosa G, Bilotta F. Effects of Anesthetic Management on Early Postoperative Recovery, Hemodynamics and Pain After Supratentorial Craniotomy. J Clin Med Res. 2015 Oct;7(10):731-41. doi: 10.14740/jocmr2256w. Epub 2015 Aug 23.'}, {'pmid': '9768772', 'type': 'BACKGROUND', 'citation': "Yared JP, Starr NJ, Hoffmann-Hogg L, Bashour CA, Insler SR, O'Connor M, Piedmonte M, Cosgrove DM 3rd. Dexamethasone decreases the incidence of shivering after cardiac surgery: a randomized, double-blind, placebo-controlled study. Anesth Analg. 1998 Oct;87(4):795-9. doi: 10.1097/00000539-199810000-00010."}, {'pmid': '24270900', 'type': 'BACKGROUND', 'citation': 'Li X, Zhou M, Xia Q, Li W, Zhang Y. Effect of parecoxib sodium on postoperative shivering: a randomised, double-blind clinical trial. Eur J Anaesthesiol. 2014 Apr;31(4):225-30. doi: 10.1097/01.EJA.0000436684.94403.1e.'}, {'pmid': '25335108', 'type': 'BACKGROUND', 'citation': 'Chen J, Chen Y, Lu KZ. Prophylactic parecoxib reduces the incidence of shivering after general anaesthesia. Eur J Anaesthesiol. 2014 Dec;31(12):714-5. doi: 10.1097/EJA.0000000000000165. No abstract available.'}, {'pmid': '25908099', 'type': 'BACKGROUND', 'citation': 'Shen H, Chen Y, Lu KZ, Chen J. Parecoxib for the prevention of shivering after general anesthesia. J Surg Res. 2015 Jul;197(1):139-44. doi: 10.1016/j.jss.2015.03.011. Epub 2015 Mar 28.'}, {'pmid': '26342782', 'type': 'BACKGROUND', 'citation': 'Teymourian H, Mohajerani SA, Bagheri P, Seddighi A, Seddighi AS, Razavian I. Effect of Ondansetron on Postoperative Shivering After Craniotomy. World Neurosurg. 2015 Dec;84(6):1923-8. doi: 10.1016/j.wneu.2015.08.034. Epub 2015 Sep 3.'}, {'pmid': '25851018', 'type': 'BACKGROUND', 'citation': 'Liu ZX, Xu FY, Liang X, Zhou M, Wu L, Wu JR, Xia JH, Zou Z. Efficacy of dexmedetomidine on postoperative shivering: a meta-analysis of clinical trials. Can J Anaesth. 2015 Jul;62(7):816-29. doi: 10.1007/s12630-015-0368-1. Epub 2015 Apr 8.'}, {'pmid': '22890247', 'type': 'BACKGROUND', 'citation': 'Park SM, Mangat HS, Berger K, Rosengart AJ. Efficacy spectrum of antishivering medications: meta-analysis of randomized controlled trials. Crit Care Med. 2012 Nov;40(11):3070-82. doi: 10.1097/CCM.0b013e31825b931e.'}]}, 'descriptionModule': {'briefSummary': 'Shivering is an early postoperative complication during the postoperative recovery period, and there is no clear consensus about the best way for its prevention. The aim of the study was to compare the efficacy and accompanying side effects of prophylactic flurbiprofen with that of parecoxib or placebo for reducing postoperative shivering.', 'detailedDescription': '154 patients with American Society of Anesthesiologists physical status I-II, who were scheduled for colorectal operation under general anesthesia, were randomly assigned to receive flurbiprofen (Group F), parecoxib sodium (Group P ) or normal saline(Group S)40min before the end of surgery. Hemodynamic parameters were monitored. The occurrence of shivering postoperative nausea and vomiting were recorded during the recovery period. And visual analogue score (VAS) and ramsy sedation scale (RSS) were also recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* One hundred and sixty-six, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the prospective, randomized, double-blind clinical study.\n* All patients who were from 21 to 62 years old and body mass index 19-35 in tumor hospital of Guangxi medical university (State of China) from April 2014 to April 2015 were included.\n\nExclusion Criteria:\n\n* Patients with cardiac, pulmonary, hepatic, renal, thyroid, or neuromuscular disease, and those who took chronic drug or abused alcohol were excluded.\n* Another patients with hypertension, gastrointestinal bleeding, an initial core temperature \\>37.5℃ or \\<36.5℃, a history of allergy to non- steroidal anti-inflammatory drugs (NSAIDs) or other agents to be used, and inability to cooperate were also excluded in this study.\n* Another patients with blood loss during operation\\>400ml, a need for blood transfusion during surgery, duration of operation\\>4h and surgical procedures changed were excluded."}, 'identificationModule': {'nctId': 'NCT02569905', 'briefTitle': 'Effect of Parecoxib Sodium and Flurbiprofen Injection on Postoperative Shivering', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'officialTitle': 'Tumor Hospital of Guangxi Medical University, China', 'orgStudyIdInfo': {'id': '2014032605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Groups Parecoxib sodium', 'description': "Fifty-one, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.", 'interventionNames': ['Drug: parecoxib sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Groups Flurbiprofen', 'description': "Fifty-two, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.", 'interventionNames': ['Drug: flurbiprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group Saline', 'description': "Fifty-one, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.", 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'parecoxib sodium', 'type': 'DRUG', 'description': 'parecoxib sodium 40mg', 'armGroupLabels': ['Groups Parecoxib sodium']}, {'name': 'flurbiprofen', 'type': 'DRUG', 'description': 'flurbiprofen 50mg', 'armGroupLabels': ['Groups Flurbiprofen']}, {'name': 'saline', 'type': 'DRUG', 'description': 'normal saline', 'armGroupLabels': ['Group Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Anesthesia Department, Tumor Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesiologists', 'investigatorFullName': 'xueke du', 'investigatorAffiliation': 'Guangxi Medical University'}}}}