AkathisiaPhase 3NCT01942343
Akathisia in Post Operative Outpatients Surgery
A Phase 3 study testing Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration in people with Akathisia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Akathisia
- What is being tested?
- Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 3
- 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
- Patient over 18 and under 65 year-old
- Having a moderate to severe POVN (post operative vomiting and nausea) risk, meaning with at least two risk factors in the simplified Apfel score
- Outpatient surgery associated to a general anesthesia
- Patient having signed an informed consent- Patient having a social protection
Who cannot join
- Contraindication to Droperidol
- Contraindication to Ondansetron
- Patients usually treated with benzodiazepine or having been treated with benzodiazepine within 2 days prior to anesthesia
- Psychiatric and Neurodegenerative diseases
- Severe Anxiety
- Contraindication to general anesthesia or one of its components
Show all 12Show fewer
- Allergy to propofol
- Inability to get informed (patient in an emergency situation, difficulties to understand)
- Patient under judicial protection
- Patient under tutorship or curatorship
- Pregnancy reported by the patient- Breastfeeding
- Patient in an exclusion period
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, 67000
About this study
Official title: Etude de l'Effet du dropéridol et de l'Ondansetron Sur l'Incidence de l'Akathisie Post opératoire en Chirurgie Ambulatoire
The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia (Barnes score > 1) in the Droperidol arms (0,625 mg and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO, that among patients taking Ondansetron.
- Conditions
- Akathisia
- Being tested
- Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administrationDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : Droperidol 1,25 mg | Active comparator | Not described Receives: Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration |
| Arm 2 : Droperidol 0,625 mg | Active comparator | Not described Receives: Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration |
| Arm 3 : Odansetron 4 mg | Active comparator | Not described Receives: Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of akathisia
The main objective of this study was to evaluate the incidence of akathisia with the waning of prophylactic treatment of PONV with droperidol used two different doses versus control group (ondansetron), ambulatory surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2015
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 AkathisiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942343
- Sponsor's protocol ID
- 5505
- Other IDs
- 2013-000905-22
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2013
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Charton A, Greib N, Ruimy A, Faitot V, Noudem Y, Joshi GP, Meyer N, Diemunsch P. Incidence of akathisia after postoperative nausea and vomiting prophylaxis with droperidol and ondansetron in outpatient surgery: A multicentre controlled randomised trial. Eur J Anaesthesiol. 2018 Dec;35(12):966-971. doi: 10.1097/EJA.0000000000000821.
PubMed 29746373
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de l'Effet du dropéridol et de l'Ondansetron Sur l'Incidence de l'Akathisie Post opératoire en Chirurgie Ambulatoire
- ClinicalTrials.gov ID
- NCT01942343
- Acronym / sponsor ID
- 5505
- Conditions
- Akathisia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Sep 2013 (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.
The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia (Barnes score > 1) in the Droperidol arms (0,625 mg and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO, that among patients taking Ondansetron.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : Droperidol 1,25 mg | Active comparator | Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration |
| Arm 2 : Droperidol 0,625 mg | Active comparator | Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration |
| Arm 3 : Odansetron 4 mg | Active comparator | Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 and under 65 year-old
- Having a moderate to severe POVN (post operative vomiting and nausea) risk, meaning with at least two risk factors in the simplified Apfel score
- Outpatient surgery associated to a general anesthesia
- Patient having signed an informed consent- Patient having a social protection
Key exclusion criteria (12 listed)
- Contraindication to Droperidol
- Contraindication to Ondansetron
- Patients usually treated with benzodiazepine or having been treated with benzodiazepine within 2 days prior to anesthesia
- Psychiatric and Neurodegenerative diseases
- Severe Anxiety
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 |
|---|---|---|
| Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration | Drug | Arm 1 : Droperidol 1,25 mg, Arm 2 : Droperidol 0,625 mg, Arm 3 : Odansetron 4 mg |
Primary outcome
Incidence of akathisia
Time frame: 1 day
The main objective of this study was to evaluate the incidence of akathisia with the waning of prophylactic treatment of PONV with droperidol used two different doses versus control group (ondansetron), ambulatory surgery
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 16 Mar 2026.
- Results publication: PubMed 29746373Charton A, Greib N, Ruimy A, Faitot V, Noudem Y, Joshi GP, Meyer N, Diemunsch P. Incidence of akathisia after postoperative nausea and vomiting prophylaxis with droperidol and ondansetron in outpatient surgery: A multicentre controlled randomised trial. Eur J Anaesthesiol. 2018 Dec;35(12):966-971. doi: 10.1097/EJA.0000000000000821.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration in people with Akathisia, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 12 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 16 Mar 2026. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of akathisia (time frame: 1 day). 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 NCT01942343, 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 16 Mar 2026.