Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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The aim is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.

Detailed Description
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Patients will be randomized to one of four arms: Ondansetron (4O-PE: 4 mg Ondansetron pre-emergence, 8O-PE: 8 mg Ondansetron pre-emergence, 4O-PI: 4 mg Ondansetron pre-incision, 8O-PI: 8 mg Ondansetron pre-incision), Dexamethasone (4D-PE: 4 mg Dexamethasone pre-emergence, 8D-PE: 8 mg Dexamethasone pre-emergence, or 4D-PI: 4 mg Dexamethasone pre-incision, or 8D-PI: 8 mg Dexamethasone pre-incision), Combination Therapy group (4O-PI+8D-PI: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-incision, 4O-PI+8D-PE: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-emergence, 4 O-PE+8D-PI: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction, 4 O-PE+8D-PE: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence), and Placebo group 2 ml Saline 0.9%. Primary outcome will be the incidence of PONV in the PACU prior to discharge.

Official Title
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Drug and Dosage Adjustment in Preventing Postoperative Nausea and Vomiting in Adult Patients Undergoing Elective Surgery Under General Anesthesia

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Other: Parallel Assignment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA grade I and II Aged 18-70 years Patients scheduled for elective surgery under general anesthesia Exclusion Criteria: All patients who received antiemetics or cortisone within 48 hr before surgery Pregnant, breast feeding ladies Any patient with BMI (Body Mass Index) > 34 kg/m² Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| O-4PI<br>4 mg Ondansetron given Pre-Induction | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| O-8PI<br>8 mg Ondansetron given Pre-Induction | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| O-4PE<br>4 mg Ondansetron given Pre-Emergence | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| O-8PE<br>8 mg Ondansetron given Pre-Emergence | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| D-4PI<br>4 mg Dexamethasone given Pre-Induction | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| D-8PI<br>8 mg Dexamethasone given Pre-Induction | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| D-4PE<br>4 mg Dexamethasone given Pre-Emergence | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| D-8PE<br>8 mg Dexamethasone given Pre-Emergence | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| O-4PI+D-8PI<br>4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| O-4PI+D-8PE<br>4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| O-4PE+D-8PI<br>4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| O-4PE+D-8PE<br>4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|
| Placebo Group<br>2 ml Saline 0.9% | Other: Parallel Assignment<br>* Prospective, Triple blinded, randomized, controlled trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of postoperative nausea and/or vomiting | Follow if the patient complained about postoperative nausea and/or vomiting in terms of use of antiemetic drugs | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, vomiting, postoperative, dose adjustment