Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet
Palabras clave
Abstracto
Descripción
See above
fechas
| Verificado por última vez: | 10/31/2015 |
| Primero enviado: | 03/02/2014 |
| Inscripción estimada enviada: | 04/13/2014 |
| Publicado por primera vez: | 04/15/2014 |
| Última actualización enviada: | 11/30/2015 |
| Última actualización publicada: | 12/02/2015 |
| Fecha de inicio real del estudio: | 03/31/2014 |
| Fecha estimada de finalización primaria: | 12/31/2014 |
| Fecha estimada de finalización del estudio: | 10/31/2015 |
Condición o enfermedad
Intervención / tratamiento
Drug: Cesamet (nabilone)
Drug: Placebo
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Cesamet (nabilone) 0.5 mg capsule containing Cesamet (single dose) given preoperatively | Drug: Cesamet (nabilone) Nabilone (0.5 mg) or placebo given preoperatively |
| Placebo Comparator: Placebo identical capsule containing placebo (single dose) given preoperatively | Drug: Placebo Placebo Comparator: identical capsule containing placebo (single dose) given preoperatively |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective surgery under general anesthesia with pre-anesthesia consultation prior to surgery. - Subjects must be able to swallow study medication; - At a risk of postoperative nausea and vomiting of at least 61% percent, according to a simplified risk score, based on the presence of at least three of the following risk factors: female sex, nonsmoker status, anticipated use of postoperative opioid and previous PONV or motion sickness. Exclusion Criteria: - Subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease - Patients who will not be admitted to the PACU post-operatively (patients who are immediately transferred to the ICU) - Known sensitivity to marijuana or other cannabinoid agents - Psychotic illness or depression - Addiction to illicit substances or alcohol - Non-psychotic emotional disorders. - Pregnant or lactating - Subjects who suffer from chronic nausea and/or vomiting; - Has had treatment with any other investigational drug within 12 weeks prior to randomization - Subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug |
Salir
Medidas de resultado primarias
1. Incidence of postoperative nausea and/or vomiting [Prior to discharge from postanesthesia care unit, an expected average of two hours]
Medidas de resultado secundarias
1. Number of antiemetic rescue medications given postoperatively. [Prior to discharge from postanesthesia care unit, an expected average of two hours]
Otras medidas de resultado
1. Standardized score of nausea and/or vomiting severity if PONV occurs. [Prior to discharge from postanesthesia care unit, an expected average of two hours]
2. Pain score during the immediate post-operative period. [Prior to discharge from postanesthesia care unit, an expected average of two hours]
3. Use of intraoperative and postoperative opioids [Prior to discharge from postanesthesia care unit, an expected average of two hours]
4. Rates of known side effects. [Prior to discharge from postanesthesia care unit, an expected average of two hours]
5. Time to discharge from the PACU. [Prior to discharge from postanesthesia care unit, an expected average of two hours]
6. Rates of admission due to PONV [Prior to discharge from postanesthesia care unit, an expected average of two hours]
7. Antiemetics given prophylactically by the anesthesiologist. [Until discharge from postanesthesia care unit, an expected average of two hours]
