Connexion
M'inscrire

Votre recherche

Filtres

Project précédent
Projet suivant
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles

2000033786

The impact of preoperative olanzapine on quality of recovery after discharge from ambulatory surgery
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05676294
olanzapine
placebo-controlled
nausea
vomiting
ambulatory surgery procedures
antiemetic
general anesthesia
Source : Importé depuis le centre
Recrutement ouvert
Dernière modification : 2024/10/07
Type de recherche

Interventionnel

Médicament expérimental

PHASE2


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

FEMALE

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Female aged 18-50
* Scheduled to undergo ambulatory surgery under general anesthesia
* Access to smartphone device or computer with internet connection and has an email address

Exclusion Criteria:

* Non-English speaking
* Unable to swallow pills
* Current use of anti-psychotic medications
* History of allergy to olanzapine
* Pregnancy/Lactation
* Current use of antihypertensive medication
* Diabetes Mellitus
* Clinically significant cardiovascular disease defined as follows:

1. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
2. History of serious ventricular arrhythmia (i.e.: ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled on anti-arrhythmic medication.
3. New York Heart Association Class II or higher congestive heart failure.
4. Postural hypotension or vasovagal syncope within 6 months of planned surgery.
* Hypotension on day of surgery, defined as a systolic blood pressure \< 90mmHg
* Seizure disorder
* Clinically active prolactinoma
* Hepatic disease
* Narrow angle glaucoma
* Parkinson's disease
* Lewy body dementia

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Olanzapine olanzapine oral tablet, 5mg, once prior to surgery Donnée non disponible
  • Inconnu
  • Placebo placebo oral tablet once prior to surgery Donnée non disponible
  • Inconnu
  • Olanzapine
    État du recrutement
    unknown
    Placebo
    État du recrutement
    unknown
    Données à jour depuis : 7 octobre 2024

    Description de l'étude

    Résumé de l'étude

    The primary objective of this phase 2 randomized controlled trial is to determine whether the pre-operative administration of olanzapine (5 mg PO) improves quality of recovery (assessed by the Quality of Recovery-40 (QoR-40) survey) on postoperative day 1 in patients having ambulatory surgery with general anesthesia.

    The secondary objectives of this study are to determine whether there are differences in quality of recovery on postoperative day 2, presence of post-discharge nausea, presence of severe post-discharge nausea, recovery room length of stay and opioid consumption in patients who receive the study drug versus placebo.

    Source : Importé depuis le centre

    Up to 37% of patients undergoing ambulatory surgery experience postdischarge nausea and vomiting (PDNV), and PDNV represents a major barrier to improving a patient's quality of recovery. Because olanzapine has been shown to be an effective drug for PDNV prevention, but carries the risk of sedation, this study seeks to identify if the administration of olanzapine is an intervention that improves a patient's overall quality of recovery.

    The study population includes women between 18 and 50 years-old who are undergoing ambulatory (outpatient) surgery at Yale New Haven Hospital. This represents the population that is most susceptible to post-discharge nausea and vomiting (PDNV) and is therefore most likely to benefit from an intervention that reduces PDNV to impact overall quality of recovery.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 7 octobre 2024
    Données à jour depuis : 26 déc.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05676294