Dexamethasone for Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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The investigators want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy.

Detailed Description
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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 .

Official Title
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Optimizing Anesthesia Antiemetic Measures Versus Combination With Dexamethasone or Ondansetron in the Prevention of Postoperative Nausea and Vomiting.

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Ondansetron
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group D<br>Dexamethasone group : This group received 8 mg dexamethasone | Drug: Dexamethasone<br>* 8 mg, Intravenous<br>|
| Active Comparator: Group O<br>Ondansetron Group: received 4 mg ondansetron | Drug: Ondansetron<br>* 4 mg, intravenously<br>|
| Placebo Comparator: Group P<br>(Group P) received normal saline (Placebo) | Drug: normal saline<br>* 2 ml, intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of nausea and vomiting in each of the three studied groups. |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the postoperative Visual Analog Score for pain assessment in each of the three studied groups |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Nausea and Vomiting, Ondansetron, Dexamethasone