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NCT03141645 Clinical Trial

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

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03141645
Other study ID # SIRB007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2017
Est. completion date April 1, 2019

Study information
Verified date April 2019
Source Siriraj Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 171
Est. completion date April 1, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Fluid loading
Patients in the preoperative intravenous fluid loading group (group F) will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation.
Drug:
• Ondansetron
Patients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation

Locations
Country Name City State
Thailand Mingkwan Wongyingsinn Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Siriraj Hospital Buddhachinaraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of postoperative nausea and vomiting The incidence of postoperative nausea and vomiting within postoperative 24 hours 24 hours
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