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

Not Applicable

Completed

• Conditions: Postoperative Vomiting; Postoperative Nausea; Postoperative Nausea and Vomiting
• Interventions: Other: Fluid loading; Drug: Ondansetron

• Registration Number: NCT03141645
• Lead Sponsor: Siriraj Hospital

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Study Start: 2017-06-20
• Primary Completion: 2018-12-31
• Status Verified: 2019-04
• Study Completion: 2019-04-01
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid loading group	Fluid loading	Patients will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation
Ondansetron group	Ondansetron	Patients will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative nausea and vomiting	24 hours	The incidence of postoperative nausea and vomiting within postoperative 24 hours

Trial Locations

Locations (1)

Mingkwan Wongyingsinn; 🇹🇭 Bangkok, Thailand