Clinical trials: Dexmedetomidine
Anesthesia, Surgical Procedures, Elective
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)
The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care (MAC).
- Trial name
- NCT00398827
- Testing
- Dexmedetomidine
- Where
- 27 sites in United States
- Volunteers
- 326 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
Sedation
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.
- Trial name
- NCT06085573
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
Bipolar I Disorder, Bipolar II Disorder
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT07116694
- Testing
- BXCL501 Sublingual Film
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- BioXcel Therapeutics Inc
Pain, Postoperative
Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy
The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch, will provide adequate pain relief during the first 3 days following bunionectomy surgery.
- Trial name
- DMTS (NCT02953054)
- Testing
- DMTS
- Where
- 2 sites in Australia
- Volunteers
- 88 people
- Sponsor
- Teikoku Pharma USA, Inc.
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
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.
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
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
Preoperative Sedation of Children
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.
- Trial name
- NCT05111431
- Testing
- Dexmedetomidine Hydrochloride Nasal Spray, Dexmedetomidine hydrochloride nasal spray blank preparation
- Where
- China
- Volunteers
- 159 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
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
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
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.
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.
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
Delirium
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG)…
- Trial name
- NCT00464763
- Testing
- Dexmedetomidine
- Where
- 11 sites in United States
- 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 With Epidural Anesthesia or Spinal Anesthesia Without Intubation
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored…
- Trial name
- NCT01438957
- Testing
- Dexmedetomidine hydrochloride
- Where
- 12 sites in Japan
- Volunteers
- 119 people
- Sponsor
- Pfizer
Agitation
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.
- Trial name
- NCT06052254
- Testing
- 12 cm2 - 2 Active DMTS Patches
- Where
- 8 sites in United States
- Volunteers
- 150 people
- Sponsor
- Teikoku Pharma USA, 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
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