Postoperative NauseaNCT03141645
Comparison of IV Fluid Loading and Ondansetron in Reduction of PONV After LC
A study testing Fluid loading and Ondansetron in people with Postoperative Nausea and Postoperative Vomiting, run by Siriraj Hospital at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Nausea, Postoperative Vomiting, Postoperative Nausea and Vomiting
- What is being tested?
- Fluid loading and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteThailand
- Study dates
- 20 Jun 2017to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with aged 18 to 70 years with an ASA physical status 1-3
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Being tested
- Fluid loading, Ondansetron
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid loadingOther
Also called Preoperative IV loading
Patients in the preoperative intravenous fluid loading group (group F) will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation.
OndansetronDrug
Also called Zetron
Patients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation
| Study group | Role | What they receive |
|---|---|---|
| Fluid loading group | Experimental | Patients will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation Receives: Other: Fluid loading |
| Ondansetron group | Active comparator | Patients will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation. Receives: Drug: Ondansetron |
| Control group | No intervention | Patients will receive neither preoperative intravenous fluid loading nor intravenous ondansetron. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative nausea and vomiting
The incidence of postoperative nausea and vomiting within postoperative 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start20 Jun 2017
- Primary completion31 Dec 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Buddhachinaraj Hospital
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
- Investigators
- Mingkwan Wongyingsinn, MD, MSc, Principal investigator, Faculty of Medicine Siririaj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141645
- Sponsor's protocol ID
- SIRB007
- Status last verified
- Apr 2019
- First submitted
- 3 May 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wongyingsinn M, Peanpanich P, Charoensawan S. A randomized controlled trial comparing incidences of postoperative nausea and vomiting after laparoscopic cholecystectomy for preoperative intravenous fluid loading, ondansetron, and control groups in a regional hospital setting in a developing country. Medicine (Baltimore). 2022 Oct 21;101(42):e31155. doi: 10.1097/MD.0000000000031155.
PubMed 36281094
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03141645
- Acronym / sponsor ID
- SIRB007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Collaborators
- Buddhachinaraj Hospital
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluid loading group | Experimental | Other: Fluid loadingPatients will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation |
| Ondansetron group | Active comparator | Drug: OndansetronPatients will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation. |
| Control group | No intervention | –Patients will receive neither preoperative intravenous fluid loading nor intravenous ondansetron. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with aged 18 to 70 years with an ASA physical status 1-3
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid loadingAlso: Preoperative IV loadingPatients in the preoperative intravenous fluid loading group (group F) will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation. | Other | Fluid loading group |
| OndansetronAlso: ZetronPatients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation | Drug | Ondansetron group |
Primary outcome
The incidence of postoperative nausea and vomiting
Time frame: 24 hours
The incidence of postoperative nausea and vomiting within postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Derived from this study: PubMed 36281094Wongyingsinn M, Peanpanich P, Charoensawan S. A randomized controlled trial comparing incidences of postoperative nausea and vomiting after laparoscopic cholecystectomy for preoperative intravenous fluid loading, ondansetron, and control groups in a regional hospital setting in a developing country. Medicine (Baltimore). 2022 Oct 21;101(42):e31155. doi: 10.1097/MD.0000000000031155.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingkwan Wongyingsinn, MD, MSc principal investigator
Faculty of Medicine Siririaj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid loading and Ondansetron in people with Postoperative Nausea and Postoperative Vomiting, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative nausea and vomiting (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.