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

Siriraj Hospital

Status: Completed

Conditions: Postoperative Nausea and Vomiting; Postoperative Vomiting; Postoperative Nausea

Treatments: Drug: Ondansetron; Other: Fluid loading

Study type: Interventional

Funder types: Other

Identifiers

NCT03141645

SIRB007

Details and patient eligibility

About

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).

Full 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).

Enrollment: 171 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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171 participants in 3 patient groups

Fluid loading group

Experimental group

Description:

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

Treatment:

Other: Fluid loading

Ondansetron group

Active Comparator group

Description:

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

Treatment:

Drug: Ondansetron

Control group

No Intervention group

Description:

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