Postoperative Nausea and VomitingPhase 4NCT02143531
Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting
A Phase 4 study testing 4 mg of Ondansetron IV and 1mg of Haloperidol IV in people with Postoperative Nausea and Vomiting, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in controlling established postoperative nausea and vomiting (PONV) in the first 24 hours following administration similar to the standard of care ondansetron 4 mg. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- 4 mg of Ondansetron IV and 1mg of Haloperidol IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteLebanon
- Study dates
- Sep 2008to Aug 2012
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80
- ASA class I, II, and III
- undergoing elective surgery under general anesthesia
Who cannot join
- Patients with history of arrhythmias, QTc prolongation or allergies to the study drugs will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Haloperidol Versus Ondansetron for Treatment of Established Nausea and Vomiting in Patients Undergoing Surgery With General Anesthesia: A Randomized Clinical Trial
This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in controlling established postoperative nausea and vomiting (PONV) in the first 24 hours following administration similar to the standard of care ondansetron 4 mg.
Read the detailed description
Patients undergoing surgery under general anesthesia may experience several complications in their postoperative period. Nausea and vomiting are some of the more common of these complications. Several medications can be used for prevention of these specific complications, but treatment remains more cost-efficient.
Haloperidol is anti-psychotic which, at low doses, can prevent the occurrence of nausea and vomiting. Its usefulness for prophylaxis has been demonstrated in several studies. However, its use for treating established postoperative nausea and vomiting (PONV) has not been properly studied.
In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, investigators will enroll 120 patients, and compare the effect of a dose of 1 mg Haloperidol versus Ondansetron 4 mg and document the varying degrees of success in treating nausea and vomiting as well as possible side effects.
Investigators expect to observe that Haloperidol is as effective as treatment with Ondansetron.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- 4 mg of Ondansetron IV, 1mg of Haloperidol IV
- 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.
4 mg of Ondansetron IVDrug
1mg of Haloperidol IVDrug
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting Receives: Drug: 4 mg of Ondansetron IV |
| Group II | Active comparator | Patients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting Receives: Drug: 1mg of Haloperidol IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
Investigators will assess the success rate of the anti-emetic used: resolution of post-operative nausea and vomiting within 30 minutes from the adminstration of the anti-emetic will be considered "success".
Measured: during the first hour postoperatively
Secondary outcomes (5)
Severity of postoperative nausea and vomiting (PONV)
Investigators will ask patients to grade the severity of their nausea episodes using the following scale:
- No nausea; 1. mild ; 2. Discomforting; 3. Distressing; 4. Horrible; 5. Worst possible
Measured: during the first 24 hours postoperatively
Recurrence of postoperative nausea and vomiting (PONV)
Measured: during first 24 hours postoperatively
Side effects in PACU
Headache, Dizzines / Vertigo, Restlessness, Nystagmus or other extra-pyramidal symptoms, Sedation highest score, Pain highest score, QT prolongation
Measured: 1 hour postoperatively
Patient satisfaction
24 hours following surgery, investigators will ask patients to grade their satisfaction with the treatment of post-operative nausea and vomiting using the following scale:
- Excellent; 2. Good; 3. Fair; 4. Bad
Measured: 24 hours after surgery
Rescue anti-emetic
Measured: during the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startSep 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marie Awad, American University of Beirut Medical Center
- Investigators
- Marie Aouad, MD, Principal investigator, American Univesity of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143531
- Sponsor's protocol ID
- ANES.MA 09
- Status last verified
- May 2014
- First submitted
- 15 May 2014
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Haloperidol Versus Ondansetron for Treatment of Established Nausea and Vomiting in Patients Undergoing Surgery With General Anesthesia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02143531
- Acronym / sponsor ID
- ANES.MA 09
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 May 2014 (estimated)
- 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 aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in controlling established postoperative nausea and vomiting (PONV) in the first 24 hours following administration similar to the standard of care ondansetron 4 mg.
Detailed description
Patients undergoing surgery under general anesthesia may experience several complications in their postoperative period. Nausea and vomiting are some of the more common of these complications. Several medications can be used for prevention of these specific complications, but treatment remains more cost-efficient.
Haloperidol is anti-psychotic which, at low doses, can prevent the occurrence of nausea and vomiting. Its usefulness for prophylaxis has been demonstrated in several studies. However, its use for treating established postoperative nausea and vomiting (PONV) has not been properly studied.
In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, investigators will enroll 120 patients, and compare the effect of a dose of 1 mg Haloperidol versus Ondansetron 4 mg and document the varying degrees of success in treating nausea and vomiting as well as possible side effects.
Investigators expect to observe that Haloperidol is as effective as treatment with Ondansetron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: 4 mg of Ondansetron IVPatients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting |
| Group II | Active comparator | Drug: 1mg of Haloperidol IVPatients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-80
- ASA class I, II, and III
- undergoing elective surgery under general anesthesia
Key exclusion criteria (1 listed)
- Patients with history of arrhythmias, QTc prolongation or allergies to the study drugs will be excluded from the study.
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 |
|---|---|---|
| 4 mg of Ondansetron IV | Drug | Group I |
| 1mg of Haloperidol IV | Drug | Group II |
Primary outcome
The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
Time frame: during the first hour postoperatively
Investigators will assess the success rate of the anti-emetic used: resolution of post-operative nausea and vomiting within 30 minutes from the adminstration of the anti-emetic will be considered "success".
5 secondary outcomes
Severity of postoperative nausea and vomiting (PONV)
Time frame: during the first 24 hours postoperatively
Recurrence of postoperative nausea and vomiting (PONV)
Time frame: during first 24 hours postoperatively
Side effects in PACU
Time frame: 1 hour postoperatively
Patient satisfaction
Time frame: 24 hours after surgery
Rescue anti-emetic
Time frame: during the first 24 hours postoperatively
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 22 May 2014.
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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.
Marie Aouad, MD principal investigator
American Univesity of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 4 mg of Ondansetron IV and 1mg of Haloperidol IV in people with Postoperative Nausea and Vomiting, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 3 inclusion and 1 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 22 May 2014. 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 Lebanon. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV) (time frame: during the first hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2014.