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Study reveals which Anti-Nausea drug causes more restlessness after surgery

NCT ID NCT01942343

Knowledge-focused Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 300 adults having outpatient surgery to see how often a condition called akathisia (a feeling of severe restlessness) occurs with two different anti-nausea drugs: Droperidol and Ondansetron. The goal was to find out if Droperidol causes more akathisia than Ondansetron. Participants received one of the drugs before surgery and were checked for restlessness 4 hours after waking up.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

300 people

The number who actually took part.

Started

Oct 2013

Finished

Oct 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

drug-induced akathisia Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Akathisia

Contacts and locations

Locations

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, Alsace, 67000, France