Akathisia in Post Operative Outpatients Surgery

University Hospital, Strasbourg, France

Status and phase: Completed; Phase 3

Conditions: Akathisia

Treatments: Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01942343

5505

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Arm 1 : Droperidol 1,25 mg

Active Comparator group

Treatment:

Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Arm 2 : Droperidol 0,625 mg

Active Comparator group

Treatment:

Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration

Arm 3 : Odansetron 4 mg

Active Comparator group

Treatment:

Drug: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration