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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03141645
Enrollment
171
Registered
2017-05-05
Start date
2017-06-20
Completion date
2019-04-01
Last updated
2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea, Postoperative Vomiting, Postoperative Nausea and Vomiting

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).

Interventions

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

DRUGOndansetron

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

Sponsors

Buddhachinaraj Hospital
CollaboratorOTHER
Siriraj Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative nausea and vomiting24 hoursThe incidence of postoperative nausea and vomiting within postoperative 24 hours

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026