- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825071
Dexamethasone for Postoperative Nausea and Vomiting
Optimizing Anesthesia Antiemetic Measures Versus Combination With Dexamethasone or Ondansetron in the Prevention of Postoperative Nausea and Vomiting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
More than half of the patients undergoing laparoscopic cholecystectomy will have postoperative nausea and vomiting (PONV). PONV is related to surgical, anesthetic and patient factors.
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 .
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Amman, Jordan, 11942
- Jordan University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- (ASA) grade I and II, aged (18-70 years) who are scheduled for elective laparoscopic cholecystectomy under general anesthesia at the department of Anesthesia and Intensive Care, University of Jordan, Amman, Jordan between November 2007 and March 2008
Exclusion Criteria:
- All patients who received antiemetics or cortisone within 48 hr before surgery or those who required opioids before and after surgeries
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group D
Dexamethasone group : This group received 8 mg dexamethasone
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8 mg, Intravenous
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Active Comparator: Group O
Ondansetron Group: received 4 mg ondansetron
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4 mg, intravenously
|
Placebo Comparator: Group P
(Group P) received normal saline (Placebo)
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2 ml, intravenously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of nausea and vomiting in each of the three studied groups.
Time Frame: 5 months
|
5 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the postoperative Visual Analog Score for pain assessment in each of the three studied groups
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Subhi M Al-Ghanem, MD, FFARCSI, University of Jordan
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Dexamethasone
- Ondansetron
Other Study ID Numbers
- UJordan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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