Clinical trials: Dexmedetomidine
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
Intensive Care Unit
Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients
The objective of this study is to characterize the hemodynamic effects of Precedex (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated post-surgical subjects in an intensive care setting.
- Trial name
- NCT01169571
- Testing
- Dexmedetomidine
- Where
- 17 sites in Canada
- Volunteers
- 373 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Posttraumatic Stress Disorder (PTSD), Sleep Disturbances and Insomnia
A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances
Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares.
- Trial name
- PTSD-PoC (NCT06685965)
- Testing
- RE03
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Reconnect Labs
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects…
- Trial name
- NCT02284243
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Baudax Bio
Gastrointestinal Endoscopy, Sedation
Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis
The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies.
- Conditions
- Gastrointestinal Endoscopy, Sedation, Dexmedetomidine
- Trial name
- NCT03632330
- Testing
- Dexmedetomidine, Midazolam, Propofol
- Where
- South Korea
- Volunteers
- 6,963 people
- Sponsor
- Pfizer
Preoperative Sedation
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children
- Trial name
- NCT04200235
- Testing
- Dexmedetomidine hydrochloride nasal spray, Dexmedetomidine hydrochloride nasal spray blank preparation.
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
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
Agitation, Delirium
Study of BXCL501 In Agitation Associated With Delirium in ICU Patients
This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD) that will safely and effectively reduce agitation associated with delirium in ICU patients.
- Trial name
- NCT05313386
- Testing
- BXCL501
- Where
- United States
- Sponsor
- BioXcel Therapeutics Inc
Agitation,Psychomotor, Dementia
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years…
- Trial name
- TRANQUILITY (NCT04251910)
- Testing
- Sublingual film containing Dexmedetomidine
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- BioXcel Therapeutics 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
Sedation
Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy…
- Trial name
- NCT03293277
- Testing
- Intranasal Dexmedetomidine, Intravenous Dexmedetomidine
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Schizophrenia, Schizo-Affective Disorder
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I
- Trial name
- NCT05025605
- Testing
- BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Where
- 5 sites in United States
- Volunteers
- 140 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation, Dementia
An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation…
- Trial name
- NCT05276830
- Testing
- BXCL501
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation, Dementia
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 28 doses within a 12-week treatment period.
- Trial name
- NCT05271552
- Testing
- BXCL501
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- BioXcel Therapeutics Inc
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation, Schizophrenia
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia.
- Conditions
- Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder
- Trial name
- SERENITY I (NCT04268303)
- Testing
- Sublingual film containing dexmedetomidine (BXCL501)
- Where
- 15 sites in United States
- Volunteers
- 380 people
- Sponsor
- BioXcel Therapeutics Inc
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
Dexmedetomidine, Postoperative Delirium
Different Administration Routes of Dexmedetomidine on Postoperative Delirium
Intravenous dexmedetomidine has been reported to decrease the occurrence of postoperative delirium (POD) in elderly patients. Nevertheless, some previous studies have indicated that intratracheal dexmedetomidine and intranasal…
- Conditions
- Dexmedetomidine, Postoperative Delirium, General Anesthesia
- Trial name
- NCT05952050
- Testing
- Dexmedetomidine
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Agitation Associated With Bipolar Disorder, Agitation,Psychomotor
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder.
- Conditions
- Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
- Trial name
- SERENITY II (NCT04276883)
- Testing
- Sublingual film containing Dexmedetomidine (BXCL501)
- Where
- 15 sites in United States
- Volunteers
- 380 people
- Sponsor
- BioXcel Therapeutics Inc