Clinical trials: Dexmedetomidine
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
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
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
Intubated and Mechanically Ventilated Pediatric Subjects
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects…
- Trial name
- NCT00652028
- Testing
- Dexmedetomidine, midazolam; fentanyl
- Where
- 9 sites in United States, Guatemala
- Volunteers
- 69 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
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
Delirium in Old Age, Anesthesia; Adverse Effect
Postoperative Dexmedetomidine in Prevention of Postoperative Delirium
The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are : 1.
- Trial name
- NCT06382961
- Testing
- Dexmedetomidine injection, Sufentanil injection
- Where
- China
- Volunteers
- 287 people
- Sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Preoperative Sedation
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults
The study is being conducted to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults.
- Trial name
- NCT04383418
- Testing
- dexmedetomidine hydrochloride nasal spray, dexmedetomidine hydrochloride nasal spray blank preparation
- Where
- China
- Volunteers
- 309 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Healthy Subjects
A Repeat Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects
This Phase 1, 16-day Repeat dose study will evaluate the safety of a Dexmedetomidine Transdermal System (DMTS) skin system in healthy adults Subjects.
- Trial name
- NCT07818330
- Testing
- Dexmedetomidine Transdermal System (DMTS)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Teikoku Pharma USA, Inc.
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.
Pain, Postoperative
Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty
The primary objective of this study is to evaluate the analgesic efficacy of Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants following abdominoplasty.
- Trial name
- NCT04242407
- Testing
- DMTS
- Where
- 4 sites in United States
- Volunteers
- 164 people
- Sponsor
- Teikoku Pharma USA, Inc.
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
Pain, Postoperative
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.
- Trial name
- DMT2111 (NCT05412992)
- Testing
- DMTS Patch
- Where
- 2 sites in United States
- Volunteers
- 179 people
- Sponsor
- Teikoku Pharma USA, Inc.
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
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
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
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
Bipolar Disorder, Schizophrenia
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Conditions
- Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder
- Trial name
- NCT06041646
- Testing
- Sublingual film containing Igalmi
- Where
- 2 sites in United States
- Volunteers
- 29 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
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