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

April 3, 2019 updated by: Mingkwan Wongyingsinn, MD, Siriraj Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Mingkwan Wongyingsinn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fluid loading group
Patients will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation
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.
Other Names:
  • Preoperative IV loading
ACTIVE_COMPARATOR: Ondansetron group
Patients will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation.
Drug: Ondansetron
Patients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation
Other Names:
  • Zetron
NO_INTERVENTION: Control group
Patients will receive neither preoperative intravenous fluid loading nor intravenous ondansetron.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Collaborators

Buddhachinaraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2017

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (ACTUAL)

May 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIRB007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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