Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-01-16 @ 10:52 PM
Study NCT ID:
NCT03134612
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Degree of pain due to Propofol Injection', 'timeFrame': 'Day 1', 'description': 'The degree of pain due to propofol injection was measured at 0 second, 15 seconds, 30 second, using verbal rating scale'}]}, 'conditionsModule': {'keywords': ['lidocain', 'ondansetron', 'pain', 'propofol'], 'conditions': ['General Anesthesia With Propofol']}, 'referencesModule': {'availIpds': [{'url': 'https://sydney.edu.au/medicine/pmri/pdf/Acute-pain-management-scientific-evidence-third-edition.pdf', 'type': 'Textbook', 'comment': 'Assessment and measurement of pain and its treatment. In: Macintyre PE SD, Schug SA, Visser EJ, Walker SM, editors. Acute pain management: scientific evidence. Melbourne: Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine; 2010.p. 35-43'}, {'url': 'http://accessanesthesiology.mhmedical.com/book.aspx?bookID=413', 'type': 'Textbook', 'comment': 'Candido KD, Winnie AP. Intravenous regional block for upper \\& lower extremity surgery. In: Hadzic A, editor. Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill; 2007. p. 565-78'}], 'references': [{'pmid': '15579060', 'type': 'BACKGROUND', 'citation': 'Marik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. doi: 10.2174/1381612043382846.'}, {'pmid': '21406529', 'type': 'BACKGROUND', 'citation': 'Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.'}, {'pmid': '9659020', 'type': 'BACKGROUND', 'citation': 'Tan CH, Onsiong MK. Pain on injection of propofol. Anaesthesia. 1998 May;53(5):468-76. doi: 10.1046/j.1365-2044.1998.00405.x.'}, {'pmid': '2200299', 'type': 'BACKGROUND', 'citation': 'Johnson RA, Harper NJ, Chadwick S, Vohra A. Pain on injection of propofol. Methods of alleviation. Anaesthesia. 1990 Jun;45(6):439-42. doi: 10.1111/j.1365-2044.1990.tb14328.x.'}, {'pmid': '10320175', 'type': 'BACKGROUND', 'citation': 'Macario A, Weinger M, Truong P, Lee M. Which clinical anesthesia outcomes are both common and important to avoid? The perspective of a panel of expert anesthesiologists. Anesth Analg. 1999 May;88(5):1085-91. doi: 10.1097/00000539-199905000-00023.'}, {'pmid': '9356111', 'type': 'BACKGROUND', 'citation': 'Ye JH, Mui WC, Ren J, Hunt TE, Wu WH, Zbuzek VK. Ondansetron exhibits the properties of a local anesthetic. Anesth Analg. 1997 Nov;85(5):1116-21. doi: 10.1097/00000539-199711000-00029.'}, {'pmid': '21179288', 'type': 'BACKGROUND', 'citation': 'Lee SK. Pain on injection with propofol. Korean J Anesthesiol. 2010 Nov;59(5):297-8. doi: 10.4097/kjae.2010.59.5.297. Epub 2010 Nov 25. No abstract available.'}, {'pmid': '16830018', 'type': 'BACKGROUND', 'citation': 'Massad IM, Abu-Ali HM, Abu-Halaweh SA, Badran IZ. Venous occlusion with lidocaine for preventing propofol induced pain. A prospective double-blind randomized study. Saudi Med J. 2006 Jul;27(7):997-1000.'}, {'pmid': '10735808', 'type': 'BACKGROUND', 'citation': 'Picard P, Tramer MR. Prevention of pain on injection with propofol: a quantitative systematic review. Anesth Analg. 2000 Apr;90(4):963-9. doi: 10.1097/00000539-200004000-00035.'}, {'pmid': '1731546', 'type': 'BACKGROUND', 'citation': 'Mangar D, Holak EJ. Tourniquet at 50 mm Hg followed by intravenous lidocaine diminishes hand pain associated with propofol injection. Anesth Analg. 1992 Feb;74(2):250-2. doi: 10.1213/00000539-199202000-00014.'}, {'pmid': '24356162', 'type': 'BACKGROUND', 'citation': 'Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.'}, {'pmid': '9416710', 'type': 'BACKGROUND', 'citation': 'Tramer MR, Reynolds DJ, Moore RA, McQuay HJ. Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized placebo-controlled trials. Anesthesiology. 1997 Dec;87(6):1277-89. doi: 10.1097/00000542-199712000-00004.'}, {'pmid': '11863320', 'type': 'BACKGROUND', 'citation': 'Paventi S, Santevecchi A, Ranieri R. Efficacy of a single-dose ondansetron for preventing post-operative nausea and vomiting after laparoscopic cholecystectomy with sevoflurane and remifentanil infusion anaesthesia. Eur Rev Med Pharmacol Sci. 2001 Mar-Apr;5(2):59-63.'}, {'pmid': '25456475', 'type': 'BACKGROUND', 'citation': 'Azimaraghi O, Aghajani Y, Molaghadimi M, Khosravi M, Eslami K, Ghadimi F, Movafegh A. Ondansetrona reduz a dor da injecao de etomidato: estudo randomico controlado. Braz J Anesthesiol. 2014 May-Jun;64(3):169-72. doi: 10.1016/j.bjan.2013.06.014. Epub 2014 Mar 7. No abstract available. Portuguese.'}, {'pmid': '10389803', 'type': 'BACKGROUND', 'citation': 'Ambesh SP, Dubey PK, Sinha PK. Ondansetron pretreatment to alleviate pain on propofol injection: a randomized, controlled, double-blinded study. Anesth Analg. 1999 Jul;89(1):197-9. doi: 10.1097/00000539-199907000-00035.'}, {'pmid': '22592573', 'type': 'BACKGROUND', 'citation': 'Zahedi H, Maleki A, Rostami G. Ondansetron pretreatment reduces pain on injection of propofol. Acta Med Iran. 2012;50(4):239-43.'}, {'pmid': '10825334', 'type': 'BACKGROUND', 'citation': 'Powell RM, Buggy DJ. Ondansetron given before induction of anesthesia reduces shivering after general anesthesia. Anesth Analg. 2000 Jun;90(6):1423-7. doi: 10.1097/00000539-200006000-00032.'}, {'pmid': '10866907', 'type': 'BACKGROUND', 'citation': 'Yeh HM, Chen LK, Lin CJ, Chan WH, Chen YP, Lin CS, Sun WZ, Wang MJ, Tsai SK. Prophylactic intravenous ondansetron reduces the incidence of intrathecal morphine-induced pruritus in patients undergoing cesarean delivery. Anesth Analg. 2000 Jul;91(1):172-5. doi: 10.1097/00000539-200007000-00032.'}, {'pmid': '10434832', 'type': 'BACKGROUND', 'citation': 'Kyriakides K, Hussain SK, Hobbs GJ. Management of opioid-induced pruritus: a role for 5-HT3 antagonists? Br J Anaesth. 1999 Mar;82(3):439-41. doi: 10.1093/bja/82.3.439.'}, {'pmid': '11474424', 'type': 'BACKGROUND', 'citation': 'Ye JH, Ponnudurai R, Schaefer R. Ondansetron: a selective 5-HT(3) receptor antagonist and its applications in CNS-related disorders. CNS Drug Rev. 2001 Summer;7(2):199-213. doi: 10.1111/j.1527-3458.2001.tb00195.x.'}, {'pmid': '26543450', 'type': 'BACKGROUND', 'citation': 'Golparvar M, Saghaei M, Saadati MA, Farsaei S. Effect of ondansetron on prevention of post-induction hypotension in elderly patients undergoing general anesthesia: A randomized, double-blind placebo-controlled clinical trial. Saudi J Anaesth. 2015 Oct-Dec;9(4):365-9. doi: 10.4103/1658-354X.159455.'}, {'pmid': '11531681', 'type': 'BACKGROUND', 'citation': 'Reddy MS, Chen FG, Ng HP. Effect of ondansetron pretreatment on pain after rocuronium and propofol injection: a randomised, double-blind controlled comparison with lidocaine. Anaesthesia. 2001 Sep;56(9):902-5. doi: 10.1046/j.1365-2044.2001.02059-6.x.'}, {'pmid': '17715139', 'type': 'BACKGROUND', 'citation': 'Bolton CM, Myles PS, Carlin JB, Nolan T. Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy. Br J Anaesth. 2007 Nov;99(5):699-703. doi: 10.1093/bja/aem236. Epub 2007 Aug 21.'}, {'pmid': '1456277', 'type': 'BACKGROUND', 'citation': 'Deegan R. Ondansetron: pharmacology of a specific 5HT3-receptor antagonist. Am J Med Sci. 1992 Dec;304(6):373-8. doi: 10.1097/00000441-199212000-00009. No abstract available.'}, {'pmid': '14674982', 'type': 'BACKGROUND', 'citation': "Brill S, Middleton W, Brill G, Fisher A. Bier's block; 100 years old and still going strong! Acta Anaesthesiol Scand. 2004 Jan;48(1):117-22. doi: 10.1111/j.1399-6576.2004.00280.x."}, {'pmid': '18774520', 'type': 'BACKGROUND', 'citation': "van Zundert A, Helmstadter A, Goerig M, Mortier E. Centennial of intravenous regional anesthesia. Bier's Block (1908-2008). Reg Anesth Pain Med. 2008 Sep-Oct;33(5):483-9. doi: 10.1016/j.rapm.2008.04.011."}, {'pmid': '4003822', 'type': 'BACKGROUND', 'citation': 'Rosenberg PH, Heavner JE. Multiple and complementary mechanisms produce analgesia during intravenous regional anesthesia. Anesthesiology. 1985 Jun;62(6):840-2. No abstract available.'}, {'pmid': '10195516', 'type': 'BACKGROUND', 'citation': 'Shevchenko Y, Jocson JC, McRae VA, Stayer SA, Schwartz RE, Rehman M, Choudhry DK. The use of lidocaine for preventing the withdrawal associated with the injection of rocuronium in children and adolescents. Anesth Analg. 1999 Apr;88(4):746-8. doi: 10.1097/00000539-199904000-00011.'}, {'pmid': '11913803', 'type': 'BACKGROUND', 'citation': 'Memis D, Turan A, Karamanlioglu B, Kaya G, Pamukcu Z. The prevention of propofol injection pain by tramadol or ondansetron. Eur J Anaesthesiol. 2002 Jan;19(1):47-51. doi: 10.1017/s0265021502000078.'}, {'pmid': '21867495', 'type': 'BACKGROUND', 'citation': 'Mahler SA, Massey G, Meskill L, Wang H, Arnold TC. Can we make the basilic vein larger? maneuvers to facilitate ultrasound guided peripheral intravenous access: a prospective cross-sectional study. Int J Emerg Med. 2011 Aug 25;4:53. doi: 10.1186/1865-1380-4-53.'}, {'pmid': '12679358', 'type': 'BACKGROUND', 'citation': 'Groothuis JT, van Vliet L, Kooijman M, Hopman MT. Venous cuff pressures from 30 mmHg to diastolic pressure are recommended to measure arterial inflow by plethysmography. J Appl Physiol (1985). 2003 Jul;95(1):342-7. doi: 10.1152/japplphysiol.00022.2003. Epub 2003 Apr 4.'}, {'pmid': '9095685', 'type': 'BACKGROUND', 'citation': 'Flaherty SA. Pain measurement tools for clinical practice and research. AANA J. 1996 Apr;64(2):133-40.'}, {'pmid': '16000093', 'type': 'BACKGROUND', 'citation': 'Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.'}, {'pmid': '2200300', 'type': 'BACKGROUND', 'citation': 'McCrirrick A, Hunter S. Pain on injection of propofol: the effect of injectate temperature. Anaesthesia. 1990 Jun;45(6):443-4. doi: 10.1111/j.1365-2044.1990.tb14329.x.'}, {'pmid': '12974598', 'type': 'BACKGROUND', 'citation': 'Aubrun F, Paqueron X, Langeron O, Coriat P, Riou B. What pain scales do nurses use in the postanaesthesia care unit? Eur J Anaesthesiol. 2003 Sep;20(9):745-9. doi: 10.1017/s0265021503001212.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in preventing pain due to propofol injection', 'detailedDescription': 'Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. After a tourniquet made from NIBP cuff were inflated, subjects were given either Ondansetron 8 mg or Lidocain 20 mg intravenously, then the tourniquet was set off. Hemodynamic data was recorded. Propofol 1 mg/kg of body weight (BW) injection was given. Verbal rating scale was used to measure pain at 0 s, 5 s and 30 s. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numeric data using uni-variate analysis and bi-variate analysis. Significant value is p\\<0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 18-65 years old\n* Subjects were planned to undergo general anesthesia with propofol\n* Subjects with Body Mass Index (BMI) 18-35 kg/m2\n* Subjects with American Society of Anesthesiologists (ASA) physical status of I-II\n* Subjects with signed informed consent.\n\nExclusion Criteria:\n\n* Subjects with allergies to propofol, lidocain, ondansetron\n* Subjects with massive cardiac disorder\n* Subjects with cardiac rhythm disorder with or without treatment\n* Subjects with unstable hemodynamic\n* Subjects with contraindication to propofol, lidocain, ondansetron\n* Subjects with intubation and ventilation difficulty\n* Subjects with decreased consciousness, seizure history or head injury\n* Subjects with analgesic treatment history\n* Subjects with pregnancy.\n\nDrop out criteria:\n\n* Subjects with allergic reactions induced by propofol, lidocain, ondansetron\n* Uncooperative subjects\n* Subjects in emergency\n* Subjects with difficult vein access in the dorsum manus\n* Subjects with infection and/or inflammation in the planned intravenous cannulation location.'}, 'identificationModule': {'nctId': 'NCT03134612', 'briefTitle': 'Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ondansetron', 'description': 'Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula', 'interventionNames': ['Drug: Ondansetron 8 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocain', 'description': 'Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula', 'interventionNames': ['Drug: Lidocain 40 mg']}], 'interventions': [{'name': 'Ondansetron 8 mg', 'type': 'DRUG', 'armGroupLabels': ['Ondansetron']}, {'name': 'Lidocain 40 mg', 'type': 'DRUG', 'armGroupLabels': ['Lidocain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Central National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Aries Perdana, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Anesthesiologist', 'investigatorFullName': 'Aries Perdana', 'investigatorAffiliation': 'Indonesia University'}}}}