Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery
NCT ID: NCT05881486
Last Updated: 2023-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
234 participants
INTERVENTIONAL
2023-06-30
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fosaprepitant
Participants undergoing thoracoscopic pneumonectomy will receive 150 mg of fosaprepitant and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.
Fosaprepitant 150 mg
150 mg fosaprepitant +100 ml normal saline
Ondansetron
Participants undergoing thoracoscopic pneumonectomy received 8 mg of ondansetron and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.
Ondansetron 8mg
8 mg Ondansetron+100 ml normal saline
Interventions
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Ondansetron 8mg
8 mg Ondansetron+100 ml normal saline
Fosaprepitant 150 mg
150 mg fosaprepitant +100 ml normal saline
Eligibility Criteria
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Inclusion Criteria
2. physical status classified by the American Society of Anesthesiologists (ASA) scale as I to III
3. Apfel score ≥ 2
4. undergoing thoracoscopic pneumonectomy
Exclusion Criteria
2. body mass index (BMI) \> 35 kg/m2
3. occurrence of episodes of nausea or vomiting within 24 h prior to surgery、motion sickness,、previous PONV、people who smoke、people with alcoholism、use of corticosteroids, psychoactive or antiemetic drugs,、hypersensitivity to the study medications
4. serious kidney, liver, lung, heart, brain or bone marrow disease
5. conversion from thoracoscopic pneumonectomy to conventional pneumonectomy
6. participation in another clinical study.
18 Years
70 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Central Contacts
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References
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Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
Dorman RB, Miller CJ, Leslie DB, Serrot FJ, Slusarek B, Buchwald H, Connett JE, Ikramuddin S. Risk for hospital readmission following bariatric surgery. PLoS One. 2012;7(3):e32506. doi: 10.1371/journal.pone.0032506. Epub 2012 Mar 7.
Parra-Sanchez I, Abdallah R, You J, Fu AZ, Grady M, Cummings K 3rd, Apfel C, Sessler DI. A time-motion economic analysis of postoperative nausea and vomiting in ambulatory surgery. Can J Anaesth. 2012 Apr;59(4):366-75. doi: 10.1007/s12630-011-9660-x. Epub 2012 Jan 6.
Andreae MH, Gabry JS, Goodrich B, White RS, Hall C. Antiemetic Prophylaxis as a Marker of Health Care Disparities in the National Anesthesia Clinical Outcomes Registry. Anesth Analg. 2018 Feb;126(2):588-599. doi: 10.1213/ANE.0000000000002582.
Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.
Bailey PL, Streisand JB, Pace NL, Bubbers SJ, East KA, Mulder S, Stanley TH. Transdermal scopolamine reduces nausea and vomiting after outpatient laparoscopy. Anesthesiology. 1990 Jun;72(6):977-80. doi: 10.1097/00000542-199006000-00005.
Apfel CC, Kranke P, Katz MH, Goepfert C, Papenfuss T, Rauch S, Heineck R, Greim CA, Roewer N. Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design. Br J Anaesth. 2002 May;88(5):659-68. doi: 10.1093/bja/88.5.659.
Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
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.
Gan T, Sloan F, Dear Gde L, El-Moalem HE, Lubarsky DA. How much are patients willing to pay to avoid postoperative nausea and vomiting? Anesth Analg. 2001 Feb;92(2):393-400. doi: 10.1097/00000539-200102000-00022.
Gan TJ, El-Molem H, Ray J, Glass PS. Patient-controlled antiemesis: a randomized, double-blind comparison of two doses of propofol versus placebo. Anesthesiology. 1999 Jun;90(6):1564-70. doi: 10.1097/00000542-199906000-00011.
Navari RM, Aapro M. Antiemetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Apr 7;374(14):1356-67. doi: 10.1056/NEJMra1515442. No abstract available.
Hesketh PJ, Van Belle S, Aapro M, Tattersall FD, Naylor RJ, Hargreaves R, Carides AD, Evans JK, Horgan KJ. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003 May;39(8):1074-80. doi: 10.1016/s0959-8049(02)00674-3.
Hata A, Okamoto I, Inui N, Okada M, Morise M, Akiyoshi K, Takeda M, Watanabe Y, Sugawara S, Shinagawa N, Kubota K, Saeki T, Tamura T. Randomized, Double-Blind, Phase III Study of Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: CONSOLE. J Clin Oncol. 2022 Jan 10;40(2):180-188. doi: 10.1200/JCO.21.01315. Epub 2021 Nov 18.
Horn CC, Wallisch WJ, Homanics GE, Williams JP. Pathophysiological and neurochemical mechanisms of postoperative nausea and vomiting. Eur J Pharmacol. 2014 Jan 5;722:55-66. doi: 10.1016/j.ejphar.2013.10.037. Epub 2013 Oct 26.
Murakami C, Kakuta N, Kume K, Sakai Y, Kasai A, Oyama T, Tanaka K, Tsutsumi YM. A Comparison of Fosaprepitant and Ondansetron for Preventing Postoperative Nausea and Vomiting in Moderate to High Risk Patients: A Retrospective Database Analysis. Biomed Res Int. 2017;2017:5703528. doi: 10.1155/2017/5703528. Epub 2017 Dec 19.
Weibel S, Rucker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD012859. doi: 10.1002/14651858.CD012859.pub2.
Other Identifiers
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KYLL-202210-072-1
Identifier Type: -
Identifier Source: org_study_id
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