AkathisiaNCT01069536
Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide
A study testing metoclopramide 10 mg in people with Akathisia and Nausea, run by Pamukkale University.
Trial summary
Study Objective: The purpose of this study is to compare the effects of metoclopramide administration in bolus versus slow infusion medications in ED patients complaining of nausea for the determination of the therapeutic effect and prevention of akathisia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- metoclopramide 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to May 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of moderate to severe nausea who not use of commonly accepted antiemetic within the previous 24 hours were eligible for this study.
- Their peripheral oxygen saturation level was 90% or over while respirating room air and free of any respiratory problems.
Who cannot join
- Patients with mild symptoms of nausea
- Altered mental status
- Abnormal vital signs
- Any known allergy to the metoclopramide
- Previously enrolled in the study
- Known renal failure or insufficiency
Show all 17Show fewer
- GIS hemorrhage, ileus and/or perforation
- Women who were pregnant and lactating
- Those with a history of epilepsy
- Admitted to the ED due to acute psychiatric symptoms
- Restless legs syndrome
- Parkinson
- Organic brain disease
- Phaeochromocytoma
- Patient with alcohol
- Anticholinergic, sedative, hypnotic, trankilizan, digoxin, cimetidine, tetracycline and levo-dopa use
- Presence of severe agitation akathisia can not be evaluated and uncooperative individuals.
About this study
Study Objective:
The purpose of this study is to compare the effects of metoclopramide administration in bolus versus slow infusion medications in ED patients complaining of nausea for the determination of the therapeutic effect and prevention of akathisia.
Read more
Methods:
This was a prospective, randomized, double-blind trial. The investigation was held between 01 March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of Medicine. The patients with moderate to severe nausea randomized and divided into two groups as for the previously planned administration type of drug. Ten mg metoclopramide was administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea scores and vital changes were recorded.
- Being tested
- metoclopramide 10 mg
- Keywords
- metoclopramide, akathisia, nausea, vomiting, antiemetic, improvement of nausea
- Medical subject headings
- Psychomotor Agitation, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoclopramide 10 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 2 minutes bolus infusion | Active comparator | Not described Receives: Drug: metoclopramide 10 mg |
| 15 minutes slow infusion | Active comparator | Not described Receives: Drug: metoclopramide 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
akathisia and nausea scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startMar 2007
- Primary completionMar 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AkathisiaStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069536
- Sponsor's protocol ID
- PAU-200/030-0515
- Status last verified
- Mar 2007
- First submitted
- 16 Feb 2010
- Last updated
- 17 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide
- ClinicalTrials.gov ID
- NCT01069536
- Acronym / sponsor ID
- PAU-200/030-0515
- Keywords
- metoclopramide, akathisia, nausea, vomiting, antiemetic, improvement of nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Feb 2010 (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.
Study Objective:
The purpose of this study is to compare the effects of metoclopramide administration in bolus versus slow infusion medications in ED patients complaining of nausea for the determination of the therapeutic effect and prevention of akathisia.
Methods:
This was a prospective, randomized, double-blind trial. The investigation was held between 01 March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of Medicine. The patients with moderate to severe nausea randomized and divided into two groups as for the previously planned administration type of drug. Ten mg metoclopramide was administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea scores and vital changes were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 minutes bolus infusion | Active comparator | Drug: metoclopramide 10 mg |
| 15 minutes slow infusion | Active comparator | Drug: metoclopramide 10 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of moderate to severe nausea who not use of commonly accepted antiemetic within the previous 24 hours were eligible for this study.
- Their peripheral oxygen saturation level was 90% or over while respirating room air and free of any respiratory problems.
Key exclusion criteria (17 listed)
- Patients with mild symptoms of nausea
- Altered mental status
- Abnormal vital signs
- Any known allergy to the metoclopramide
- Previously enrolled in 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 |
|---|---|---|
| metoclopramide 10 mg | Drug | 15 minutes slow infusion, 2 minutes bolus infusion |
Primary outcome
akathisia and nausea scores
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 17 Feb 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing metoclopramide 10 mg in people with Akathisia and Nausea, run by Pamukkale University.
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 2 inclusion and 17 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
akathisia and nausea scores. 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 17 Feb 2010.