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Completed

NCT Number: NCT03141645

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

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).

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Key information

Conditions

Postoperative Nausea Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mingkwan Wongyingsinn

Bangkok, 10700, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid Loading

Other

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

ondansetron

Drug

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

Other names: Zetron

Primary outcomes

  1. The incidence of postoperative nausea and vomiting

    Time frame: 24 hours

    The incidence of postoperative nausea and vomiting within postoperative 24 hours

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Collaborators

  • Buddhachinaraj Hospital

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 5, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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