Clinical trials: Sedation;
Sedation
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects.
- Trial name
- NCT00875550
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 37 sites in United States, Canada
- Volunteers
- 175 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading…
- Trial name
- NCT01159262
- Testing
- Midazolam, Fentanyl/Morphine, Dexmedetomidine
- Where
- 18 sites in United States, Guatemala
- Volunteers
- 36 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation, Pain
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through <24 months, administered as an intravenous…
- Trial name
- NCT01378988
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation
The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation under monitored sedation care.
- Trial name
- NCT01438931
- Testing
- DA-9501
- Where
- 18 sites in Japan
- Volunteers
- 162 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation
Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects
Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.
- Trial name
- NCT00526760
- Testing
- Dexmedetomidine
- Where
- 10 sites in Japan
- Volunteers
- 80 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation, Anxiety
A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure
The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam.
- Conditions
- Sedation, Anxiety, Pain
- Trial name
- NCT00894699
- Testing
- Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Talphera, Inc
Sedation
A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations
The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete…
- Trial name
- NCT01127438
- Testing
- fospropofol disodium Subgroup 1 Lower Dose, fospropofol disodium Subgroup 1 Approved Dose, fospropofol disodium Subgroup 2 Lower Dose
- Where
- 23 sites in United States
- Volunteers
- 153 people
- Sponsor
- Eisai Inc.
Safety, Tolerability
Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years)…
- Conditions
- Safety, Tolerability, Pharmacokinetics, Sedation
- Trial name
- AZD3043 (NCT01086813)
- Testing
- AZD3043
- Volunteers
- healthy volunteers welcome
- Sponsor
- AstraZeneca
Procedural Sedation
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation.
- Trial name
- NCT00327392
- Testing
- AQUAVAN® (fospropofol disodium) Injection
- Where
- 15 sites in United States
- Volunteers
- 123 people
- Sponsor
- Eisai Inc.
Continuous Sedation in Initially Sedated Adults in ICU
Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)
Patients in ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable.
- Trial name
- MIDEX (NCT00481312)
- Testing
- Dexmedetomidine, Midazolam
- Where
- 43 sites in Belgium, Estonia and 7 more
- Volunteers
- 501 people
- Sponsor
- Orion Corporation, Orion Pharma
Colonoscopy, Endoscopy, Digestive System
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures.
- Conditions
- Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
- Trial name
- NCT00452426
- Testing
- Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System), benzodiazepines and opioid sedation
- Where
- 7 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Ethicon Endo-Surgery
Continuous Sedation in Initially Sedated Adults in ICU
Dexmedetomidine Versus Propofol for Continuous Sedation in the Intensive Care Unit (ICU)
Patients in the ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable.
- Trial name
- Prodex (NCT00479661)
- Testing
- Dexmedetomidine, Propofol
- Where
- 40 sites in Belgium, Finland and 5 more
- Volunteers
- 500 people
- Sponsor
- Orion Corporation, Orion Pharma
Pharmacokinetics, Sedation
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
The study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.
- Trial name
- DEX PK (NCT00747721)
- Testing
- Dexmedetomidine
- Where
- Finland
- Volunteers
- 13 people
- Sponsor
- Orion Corporation, Orion Pharma
Postoperative Sedation, Intubation
GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
Patients who are in the intensive care unit after surgery and require mechanical breathing support (intubation and ventilation) usually require sedation to avoid agitation and excessive stress responses.
- Conditions
- Postoperative Sedation, Intubation, Respiration, Artificial
- Trial name
- NCT00125398
- Testing
- AQUAVAN (fospropofol disodium; GPI 15715 )
- Where
- 17 sites in United States
- Volunteers
- 60 people
- Sponsor
- Eisai Inc.
Conscious Sedation
An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy
Very often patients receive medication before a diagnostic procedure, like a colonoscopy, to help them relax and stay calm during the procedure. This is called procedural or minimal-to-moderate sedation.
- Trial name
- NCT00261599
- Testing
- AQUAVAN® (fospropofol disodium) Injection, Midazolam HCI
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- Eisai Inc.
Sedation
Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU…
- Trial name
- NCT00158873
- Testing
- midazolam, lorazepam, fentanyl
- Where
- 15 sites in Netherlands
- Volunteers
- 224 people
- Sponsor
- GlaxoSmithKline
Sedation for Non-Emergent Upper and/or Lower Endoscopy
Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices
This is a 300 subject prospective study to assess cardiorespiratory events associated with current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider sedation (150 subjects; propofol) for upper…
- Trial name
- NCT00559260
- Testing
- Passive monitoring with pulse-oximetry, NIBP and ECG
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Ethicon Endo-Surgery
Conscious Sedation
Dexmedetomidine for Continuous Sedation
The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay intensive care unit…
- Trial name
- NCT00226785
- Testing
- Dexmedetomidine
- Where
- 4 sites in Finland, Switzerland
- Volunteers
- 900 people
- Sponsor
- Orion Corporation, Orion Pharma