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

Primary Purpose

Postoperative Nausea, Postoperative Vomiting, Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Fluid loading
Ondansetron
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mingkwan Wongyingsinn

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Fluid loading group

Ondansetron group

Control group

Arm Description

Patients will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation

Patients will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation.

Patients will receive neither preoperative intravenous fluid loading nor intravenous ondansetron.

Outcomes

Primary Outcome Measures

The incidence of postoperative nausea and vomiting
The incidence of postoperative nausea and vomiting within postoperative 24 hours

Secondary Outcome Measures

Full Information

First Posted
May 3, 2017
Last Updated
April 3, 2019
Sponsor
Siriraj Hospital
Collaborators
Buddhachinaraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03141645
Brief Title
Comparison of IV Fluid Loading and Ondansetron in Reduction of PONV After LC
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital
Collaborators
Buddhachinaraj Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea, Postoperative Vomiting, Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluid loading group
Arm Type
Experimental
Arm Description
Patients will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation
Arm Title
Ondansetron group
Arm Type
Active Comparator
Arm Description
Patients will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will receive neither preoperative intravenous fluid loading nor intravenous ondansetron.
Intervention Type
Other
Intervention Name(s)
Fluid loading
Other Intervention Name(s)
Preoperative IV loading
Intervention Description
Patients in the preoperative intravenous fluid loading group (group F) will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zetron
Intervention Description
Patients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation
Primary Outcome Measure Information:
Title
The incidence of postoperative nausea and vomiting
Description
The incidence of postoperative nausea and vomiting within postoperative 24 hours
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingkwan Wongyingsinn, MD, MSc
Organizational Affiliation
Faculty of Medicine Siririaj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mingkwan Wongyingsinn
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36281094
Citation
Wongyingsinn M, Peanpanich P, Charoensawan S. A randomized controlled trial comparing incidences of postoperative nausea and vomiting after laparoscopic cholecystectomy for preoperative intravenous fluid loading, ondansetron, and control groups in a regional hospital setting in a developing country. Medicine (Baltimore). 2022 Oct 21;101(42):e31155. doi: 10.1097/MD.0000000000031155.
Results Reference
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Comparison of IV Fluid Loading and Ondansetron in Reduction of PONV After LC

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