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Trial record 50 of 149 for:    Recruiting, Not yet recruiting, Available Studies | "Vomiting"

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

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ClinicalTrials.gov Identifier: NCT03141645
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Buddhachinaraj Hospital
Information provided by (Responsible Party):
Mingkwan Wongyingsinn, MD, Siriraj Hospital

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).

Condition or disease Intervention/treatment Phase
Postoperative Nausea Postoperative Vomiting Postoperative Nausea and Vomiting Other: Fluid loading Drug: Ondansetron Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Zetron

No Intervention: Control group
Patients will receive neither preoperative intravenous fluid loading nor intravenous ondansetron.



Primary Outcome Measures :
  1. The incidence of postoperative nausea and vomiting [ Time Frame: 24 hours ]
    The incidence of postoperative nausea and vomiting within postoperative 24 hours



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141645


Contacts
Contact: Mingkwan Wongyingsinn, MD, MSc +6624197990 ext 111 minkcheerful@hotmail.com

Locations
Thailand
Mingkwan Wongyingsinn Recruiting
Bangkok, Thailand, 10700
Contact: Mingkwan Wongyingsinn, MD, MSc    +6624197990 ext 111    minkcheerful@hotmail.com   
Sponsors and Collaborators
Siriraj Hospital
Buddhachinaraj Hospital
Investigators
Principal Investigator: Mingkwan Wongyingsinn, MD, MSc Faculty of Medicine Siririaj Hospital

Responsible Party: Mingkwan Wongyingsinn, MD, Assistant Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT03141645     History of Changes
Other Study ID Numbers: SIRB007
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents