NCT03141645

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

May 3, 2017

Last Update Submit

April 3, 2019

Conditions

Postoperative NauseaPostoperative VomitingPostoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative nausea and vomiting

    The incidence of postoperative nausea and vomiting within postoperative 24 hours

    24 hours

Study Arms (3)

Fluid loading group

EXPERIMENTAL

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

Other: Fluid loading

Ondansetron group

ACTIVE COMPARATOR

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

Drug: Ondansetron

Control group

NO INTERVENTION

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

Interventions

Fluid loadingOTHER

Patients in the preoperative intravenous fluid loading group (group F) will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation.

Also known as: Preoperative IV loading
Fluid loading group
OndansetronDRUG

Patients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation

Also known as: Zetron
Ondansetron group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with aged 18 to 70 years with an ASA physical status 1-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mingkwan Wongyingsinn

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 36281094DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Mingkwan Wongyingsinn, MD, MSc

    Faculty of Medicine Siririaj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 5, 2017

Study Start

June 20, 2017

Primary Completion

December 31, 2018

Study Completion

April 1, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)