Comparison of IV Fluid Loading and Ondansetron in Reduction of PONV After LC

Study Overview
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Brief Summary
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This study is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C).

Detailed Description
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This study is a prospective randomized control trial. It is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C). This study is hypothesized that the incidence of PONV in patients receiving preoperative intravenous fluid loading (group F) and patients receiving ondansetron (group O) will be similarly reduced from the control group (receiving neither fluid nor ondansetron).

Official Title
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Comparison of Preoperative Intravenous Fluid Loading and Ondansetron in Reduction of Incidence Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study

Conditions
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Postoperative Nausea, Postoperative Vomiting, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Other: Fluid loading
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with aged 18 to 70 years with an ASA physical status 1-3 Exclusion Criteria including patients with pregnant or breast-feeding patients having history of taking antiemetic drugs within 24 hours before surgery with hypersensitivity or allergy to ondansetron with CKD stage 4, 5 with congestive heart failure, LVEF <40 with cirrhosis child c refusal or cannot communicate or understand the purpose of this study

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluid loading group<br>Patients will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation | Other: Fluid loading<br>* Patients in the preoperative intravenous fluid loading group (group F) will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation.<br>* Other names: Preoperative IV loading;|
| Active Comparator: Ondansetron group<br>Patients will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation. | Drug: Ondansetron<br>* Patients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation<br>* Other names: Zetron;|
| No Intervention: Control group<br>Patients will receive neither preoperative intravenous fluid loading nor intravenous ondansetron. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative nausea and vomiting | The incidence of postoperative nausea and vomiting within postoperative 24 hours | 24 hours |