Dexmed/Buspirone Synergism on Shivering
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EstadoTerminado
Patrocinadores
The Cleveland Clinic
ENSAYO CLÍNICO: NCT00334360
BioSeek: nct00334360
Palabras clave
Abstracto
The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia.
The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration.
Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.
fechas
Verificado por última vez: | 05/31/2016 |
Primero enviado: | 06/05/2006 |
Inscripción estimada enviada: | 06/05/2006 |
Publicado por primera vez: | 06/06/2006 |
Última actualización enviada: | 06/26/2016 |
Última actualización publicada: | 06/28/2016 |
Fecha de inicio real del estudio: | 08/31/2004 |
Fecha estimada de finalización primaria: | 07/31/2007 |
Fecha estimada de finalización del estudio: | 07/31/2007 |
Condición o enfermedad
Hypothermia
Intervención / tratamiento
Drug: 1
Drug: 2
Drug: 3
Drug: Control
Fase
Fase 4
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Experimental: 1 dexmedetomidine | Drug: 1 Dexmedetomidine (delivered by a computer-controlled IV infusion to target a plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia |
Experimental: 2 Buspirone | Drug: 2 Buspirone, 60 mg orally, will be given during controlled hypothermia. |
Experimental: 3 Buspirone and dexmedetomidine | Drug: 3 the combination of 60 mg buspirone and dexmedetomidine (target plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia |
Placebo Comparator: Control No drug | Drug: Control No drugs given during controlled hypothermia |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | Male |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - 18-40 years - normal weight (BMI <35) - healthy Exclusion Criteria: - obese (BMI >35) - taking any drugs - thyroid disease, dysautonomia, or Raynaud's syndrome - severe claustrophobia |
Salir
Medidas de resultado primarias
1. Shivering threshold [3 hours]
2. maximum intensity of shivering [3 hours]
3. gain of shivering [3 hours]
Medidas de resultado secundarias
1. hemodynamic responses [3 hours]