Clinical trials: Sedated ICU Patients
Sedation
A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation
This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol…
- Trial name
- NCT04147416
- Testing
- HSK3486 0.1-0.2 /0.3 mg / kg group, Propofol 0.5-1.0/1.5 mg/kg group
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Mechanically Ventilated and Intubated Subjects
A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.
- Trial name
- NCT00216190
- Testing
- Dexmedetomidine HCL Injection, Midazolam Injection
- Where
- 96 sites in United States, Argentina and 3 more
- Volunteers
- 420 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
General Anesthesia
Remimazolam Phase II Cardiac Anesthesia Study
This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general…
- Trial name
- NCT01937767
- Testing
- Remimazolam, Propofol, Sevoflurane
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Paion UK Ltd.
Anesthesia
Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery
This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia. Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil as opioid analgesics and a neuromuscular…
- Trial name
- NCT02523859
- Testing
- Propofol, Remimazolam
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Paion UK Ltd.
Post-Intensive Care Syndrome, Sedation
A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol
This pooled analysis will assess Cognitive, Mental Health, Functioning, and Quality of Life Assessments data from the Phase 3 registration studies INSPiRE-ICU 1 (NCT05312385) and INSPiRE-ICU 2 (NCT05327296) to explore potential…
- Trial name
- NCT06809218
- Testing
- Inhaled isoflurane administered by Sedaconda ACD-S, Intravenous infusion of propofol
- Where
- United States
- Volunteers
- 312 people
- Sponsor
- Sedana Medical
Sedation
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)
This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU)…
- Trial name
- INSPiRE-ICU1 (NCT05312385)
- Testing
- Isoflurane, Propofol, Isoflurane (run-ins)
- Where
- 14 sites in United States
- Volunteers
- 277 people
- Sponsor
- Sedana Medical
Sedation
Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mechanically Ventilated Intensive Care Unit Patients
The purpose of this Expanded Access Protocol is to provide access to inhaled isoflurane delivered via the Sedaconda ACD-S device for sedation of adult patients in the ICU that are mechanically ventilated and are difficult to…
- Trial name
- NCT07457593
- Testing
- Isoflurane, Sedaconda ACD-S
- Sponsor
- Sedana Medical
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
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
Sedated ICU Patients
IMPROVE Critical Care Study (Pilot)
The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial comparing sedation management using a protocol based on responsiveness with standard sedation management.
- Trial name
- NCT01361230
- Testing
- "Sedation Trial Monitor" is the name of the device used.
- Where
- United Kingdom
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
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.
Sedation
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)
This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU)…
- Trial name
- INSPiRE-ICU2 (NCT05327296)
- Testing
- Isoflurane, Propofol
- Where
- 16 sites in United States
- Volunteers
- 282 people
- Sponsor
- Sedana Medical
ICU Sedation
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor
- Trial name
- Pedrux (NCT03813277)
- Testing
- Dexmedetomidine
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Orion Corporation, Orion Pharma
Sedation in Intensive Care
A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical Ventilation
This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the…
- Trial name
- NCT04669821
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
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
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
Sedation in Intensive Care
A Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation
This is a multi-center, randomized, single-blind, propofol-controlled phase III clinical study. In this study, ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the…
- Trial name
- NCT04620031
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.