Study Results
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Basic Information
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COMPLETED
PHASE4
180 participants
INTERVENTIONAL
2007-11-30
2008-03-31
Brief Summary
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Detailed Description
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We want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of PONV in patients undergoing laparoscopic cholecystectomy.
Three groups to be studied : (Group O) will receive 4 mg ondansetron, (Group D) will receive 8 mg dexamethasone and (Group P) will receive normal saline .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group D
Dexamethasone group : This group received 8 mg dexamethasone
Dexamethasone
8 mg, Intravenous
Group O
Ondansetron Group: received 4 mg ondansetron
Ondansetron
4 mg, intravenously
Group P
(Group P) received normal saline (Placebo)
normal saline
2 ml, intravenously
Interventions
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Dexamethasone
8 mg, Intravenous
Ondansetron
4 mg, intravenously
normal saline
2 ml, intravenously
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant, breast feeding ladies
* Any patient with BMI (Body Mass Index) \> 34 kg/m²
* Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses or those with history of motion sickness were also excluded from the study protocol
18 Years
70 Years
ALL
No
Sponsors
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University of Jordan
OTHER
Responsible Party
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Subhi M. Alghanem
Professor of Anesthesia and Intensive Care
Principal Investigators
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Subhi M Al-Ghanem, MD, FFARCSI
Role: PRINCIPAL_INVESTIGATOR
University of Jordan
Locations
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Jordan University Hospital
Amman, , Jordan
Countries
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References
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Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and prevention. Anesthesiology. 1992 Jul;77(1):162-84. doi: 10.1097/00000542-199207000-00023.
Thune A, Appelgren L, Haglind E. Prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. A prospective randomized study of metoclopramide and transdermal hyoscine. Eur J Surg. 1995 Apr;161(4):265-8.
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.
Nesek-Adam V, Grizelj-Stojcic E, Rasic Z, Cala Z, Mrsic V, Smiljanic A. Comparison of dexamethasone, metoclopramide, and their combination in the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Surg Endosc. 2007 Apr;21(4):607-12. doi: 10.1007/s00464-006-9122-7. Epub 2007 Feb 7.
Chohedri AH, Matin M, Khosravi A. The impact of operative fluids on the prevention of postoperative anesthetic complications in ambulatory surgery--high dose vs low dose. Middle East J Anaesthesiol. 2006 Oct;18(6):1147-56.
Cechetto DF, Diab T, Gibson CJ, Gelb AW. The effects of propofol in the area postrema of rats. Anesth Analg. 2001 Apr;92(4):934-42. doi: 10.1097/00000539-200104000-00027.
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.
Other Identifiers
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UJordan
Identifier Type: -
Identifier Source: org_study_id
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