Clinical trials: Dexmedetomidine, completed
Critical Illness
Alpha 2 Agonists for Sedation to Produce Better Outcomes From Critical Illness (A2B Trial)
Many patients in intensive care (ICU) need help to breathe on a breathing machine and need pain killers and sedatives to keep them comfortable and pain free.
- Trial name
- A2B (NCT03653832)
- Testing
- Dexmedetomidine, Clonidine, Propofol
- Where
- 38 sites in United Kingdom
- Volunteers
- 1,404 people
- Sponsor
- University of Edinburgh
Postoperative Delirium, Sleep
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep
This study aims to determine whether, compared with placebo, the nighttime administration of a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in extubated post-cardiac surgical…
- Conditions
- Postoperative Delirium, Sleep, Anesthesia
- Trial name
- MINDDS (NCT02856594)
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 469 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
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
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
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
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
Delirium, Agitation
Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)
The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients
- Trial name
- 4D (NCT03317067)
- Testing
- Dexmedetomidine
- Where
- France
- Volunteers
- 168 people
- Sponsor
- University Hospital, Clermont-Ferrand
Sleep, Sedation Complication
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Prospective within-subject study of dexmedetomidine sedation paired with CLAS conditions in repeated blocks. Intervention will consist of CLAS in-phase with EEG slow waves.
- Trial name
- CLASS-D (NCT04206059)
- Testing
- MRI, Quantitative Sensory Testing (QST), Home sleep study
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Analgesia, Anesthesia
Neuroimaging Study of Dexmedetomidine-Induced Analgesia
Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects.
- Trial name
- NCT04656470
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Rib Fractures, Pain, Acute
Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial
Blunt chest trauma is the second most common form of unintentional trauma in the US and is associated with significant morbidity and mortality. Thoracic injuries are the third most common cause of death in trauma patients.
- Trial name
- NCT05321121
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of California, Irvine
Hypoxic-Ischemic Encephalopathy, Pain
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure.
- Trial name
- DICE (NCT04772222)
- Testing
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
Morbid Obesity, Postoperative Pain
Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery
This prospective randomized controlled trial aims to compare the clinical effectiveness and safety of opioid-free anesthesia (OFA) versus traditional opioid-based anesthesia (OBA) in adult patients undergoing laparoscopic…
- Conditions
- Morbid Obesity, Postoperative Pain, Opioid Free Anesthesia, Bariatric Surgery
- Trial name
- NCT07337135
- Testing
- Opioid-Based Anesthesia (Remifentanil-Based Protocol), Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol)
- Where
- Portugal
- Volunteers
- 60 people
- Sponsor
- Hospital dos Lusíadas
Peripheral Vascular Diseases, Hyperglycaemia (Diabetic)
Peripheral Nerve Blocks for Above-the-knee Amputations
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral…
- Conditions
- Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension, Coronary Artery Disease
- Trial name
- NCT03404180
- Testing
- Peripheral nerve block, Intravenous Sedatives, Lateral femoral cutaneous nerve blocks
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
Postoperative Delirium, Hemodynamic Instability
Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing carDiac surgERies
In the PATHFINDER 2 trial, the study investigators will test the intraoperative EEG-guided multimodal general anesthesia (MMGA) management strategy in combination with a postoperative protocolized analgesic approach to: 1.
- Conditions
- Postoperative Delirium, Hemodynamic Instability, Pain, Neurocognitive Dysfunction
- Trial name
- PATHFINDERII (NCT05279898)
- Testing
- EEG Monitoring, Ropivacaine, Ketamine
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Beth Israel Deaconess Medical Center
Critical Illness, Anxiety
Self-management of Sedative Therapy by Ventilated Patients
The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for the self-management of sedative therapy (SMST) in a sample of critically ill patients receiving mechanical ventilator support.
- Conditions
- Critical Illness, Anxiety, Respiratory Failure
- Trial name
- NCT02819141
- Testing
- Dexmedetomidine
- Where
- 2 sites in United States
- Volunteers
- 161 people
- Sponsor
- Mayo Clinic
Congenital Heart Disease
Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation.
- Trial name
- NCT02492269
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Aymen N Naguib
Emergence Delirium
Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia
Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel.
- Trial name
- NCT06482125
- Testing
- Dexmedetomidine, Sevoflurane
- Where
- Indonesia
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Pelita Harapan University
Pregnancy Related
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
The purpose of this randomized controlled trial is to compare the effectiveness of epidural clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia.
- Trial name
- NCT05487196
- Testing
- Clonidine, Dexmedetomidine, Fentanyl
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS