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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2019-04-01

Brief Summary

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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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Detailed Description

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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).

Conditions

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Postoperative Nausea Postoperative Vomiting Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fluid loading group

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

Group Type EXPERIMENTAL

Fluid loading

Intervention Type OTHER

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

Ondansetron group

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

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Ondansetron

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

Intervention Type DRUG

Other Intervention Names

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Preoperative IV loading Zetron

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No