Clinical trials: Sedation
MRI Sedation
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to <17 years of age undergoing…
- Trial name
- NCT04237792
- Testing
- dexmedetomidine, propofol
- Where
- 23 sites in United States, Japan
- Volunteers
- 128 people
- Sponsor
- Pfizer
Operative Sedation of Pediatric, Operative Sedation of Adolescent Patients
A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
- Trial name
- NCT07036419
- Testing
- Remimazolam Tosilate for injection, Propofol Injection
- Where
- China
- Volunteers
- 249 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Perennial Allergic Rhinitis
A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis.
- Trial name
- NCT01918033
- Testing
- Desloratadine 5 mg
- Volunteers
- 608 people
- Sponsor
- Organon and Co
Colonoscopy, Colonic Polyps
Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy
Very often, patients receive sedative medication 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
- NCT00125424
- Testing
- AQUAVAN® (fospropofol disodium) Injection, Midazolam HCl
- Where
- 20 sites in United States
- Volunteers
- 125 people
- Sponsor
- Eisai Inc.
Conscious Sedation
Post-Marketing Clinical Study to Assess Efficacy and Safety of Dexmedetomidine in Post-Operative Patients
The purpose of this study is to assess efficacy and safety of dexmedetomidine at the time of extubation and after extubation, in patients requiring postoperative sedation in the ICU.
- Trial name
- NCT00318955
- Testing
- Dexmedetomidine, Propofol
- Where
- 13 sites in Japan
- Volunteers
- 85 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Colonoscopy
Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing Colonoscopy
This is a phase II, two-part, multiple-dose, dose-finding, single-blind study in adult participants undergoing elective colonoscopy for screening or diagnostic purposes.
- Trial name
- ABP-700 (NCT02800590)
- Testing
- ABP-700
- Where
- 3 sites in Netherlands
- Volunteers
- 150 people
- Sponsor
- The Medicines Company
Critical Illness
Lorazepam Sedation for Critically Ill Children
This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs.
- Trial name
- NCT00109395
- Testing
- Lorazepam, Midazolam, Lorazepam CI
- Where
- United States
- Volunteers
- 179 people
- Sponsor
- The Emmes Company, LLC
Colonoscopy
Digital Sedation: Virtual Reality Hypnosis During Colonoscopy
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit…
- Trial name
- COLDiS (NCT04465383)
- Testing
- Aqua© 30 on Oncomfort SedakitTM, Propofol
- Where
- Belgium
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Oncomfort
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
Anesthesia, Sedation
A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV…
- Trial name
- NCT03745625
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Healthy
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043
The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).
- Trial name
- NCT00984880
- Testing
- AZD3043
- Where
- Sweden
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Awake Fiberoptic Intubation
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation for Elective Awake Fiberoptic Intubation
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.
- Trial name
- NCT00383890
- Testing
- Dexmedetomidine HCL Injection
- Where
- 17 sites in United States
- Volunteers
- 124 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Procedural Sedation, Gastrointestinal Endoscopy
SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation
The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a…
- Trial name
- NCT07749781
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- Predictheon Medical, S.L.
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
Anesthesia
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)
The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.
- Trial name
- SONORA (NCT04466384)
- Testing
- BIS
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Complication of Gastrostomy
Etomidate Emulsion for Sedation in Patients Scheduled for Upper Gastrointestinal (GI) Endoscopy
The study is designed to explore and compare the efficacy and safety of etomidate and propofol with or without analgesic for painless gastroscopy, and to provide more reliant support for implementation and promotion of comfort…
- Trial name
- NCT01729897
- Testing
- Etomidate, Fentanyl, Propofol
- Volunteers
- 328 people
- Sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
Sedation
Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy
The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.
- Trial name
- NCT01145222
- Testing
- A. CNS 7056, B. CNS 7056, C. CNS 7056
- Where
- 9 sites in United States
- Volunteers
- 162 people
- Sponsor
- Paion UK Ltd.
Airway Obstruction, Apnea
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy
The primary goal of this study is to determine the effectiveness and safety of delivering continuous negative external pressure (cNEP) to the upper airway as a means of preventing episodes of respiratory impairment (RI) such as…
- Conditions
- Airway Obstruction, Apnea, Hypopnea
- Trial name
- NCT01895062
- Testing
- Airway Management System (AMS)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- 5i Sciences, Inc.
Procedural Sedation
Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers
- Trial name
- NCT04767035
- Testing
- midazolam / ketamine sublingual tablet
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Melt Pharmaceuticals