Clinical trials: Dexmedetomidine
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
Ultrasound, CT Scans
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic…
- Conditions
- Ultrasound, CT Scans, MRIs
- Trial name
- NCT01519167
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 91 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
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
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.
Delirium
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery
The purpose of this study is to evaluate the efficacy and safety of perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia.
- Trial name
- NCT00460473
- Testing
- Dexmedetomidine
- Where
- 30 sites in United States
- Volunteers
- 52 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Agitation,Psychomotor, Bipolar I Disorder
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform…
- Conditions
- Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia
- Trial name
- NCT05658510
- Testing
- BXCL501
- Where
- 24 sites in United States
- Volunteers
- 452 people
- Sponsor
- BioXcel Therapeutics Inc
Endoscopic Sinus Surgery
The Effect of Dexmedetomidine, Melatonin and Pregabalin
Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc.
- Trial name
- NCT05829148
- Testing
- Dexmedetomidine, Melatonin, Pregabalin
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Egymedicalpedia
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute…
- Trial name
- NCT02169336
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- Baudax Bio
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
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
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
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, 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.
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
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.
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.
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