13 completed, 2 suspended, 2 unknown, 1 not yet recruiting. 18 Phase 2, 5 Phase 3, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 18 | Completed 13, Suspended 2, Unknown 2, Not yet recruiting 1 |
| Phase 3 | 5 | Completed 3, Suspended 2 |
| Phase 1 | 3 | Completed 1, Not yet recruiting 1, Unknown 1 |
Follow Sedation: new trials by email Literature Review of Sedation trials Research Report on Sedation
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evaluate if Intranasal Dexmedetomidine is Better Than Intranasal Ketamine in Producing Sedation and Reducing Parent Separation Anxiety Before Surgery. Intranasal dexmedetomidine, Intranasal ketamine - Sedation, Preoperative Anxiety Experienced by the Pediatric Patient | Phase 1 / Phase 2 | Not yet recruiting | Liaquat National Hospital & Medical College | 60 | 2026-01-01 | 2025-09-18 |
| Esketamine Combined With Dexmedetomidine Sedation in Head MRI Examination of Children With Autism Spectrum Disorder low dos dexmedetomidine, high dos dexmedetomidine, dexmedetomidine and esketamine - Autism Spectrum Disorder, Dexmedetomidine | Phase 2 | Completed | Maternal and Child Health Hospital of Hubei Province | 300 | 2022-12-01 | 2024-10-09 |
| Risk Prediction of Dexmedetomidine-associated Hemodynamic Instability DEX 0.2 μg/kg/h. - Sedation | Phase 2 / Phase 3 | Suspended | Assiut University | 250 | 2021-06-01 | 2021-01-14 |
| Pre-emptive Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section Pregabalin 150mg, multivitamin - Anxiety State, Sedation | Phase 1 / Phase 2 | Unknown | Zagazig University | 74 | 2020-11-15 | 2021-02-04 |
| Dexmedetomidine Sedation in Orthopedic Surgery Dexmedetomidine, Midazolam, Remifentanil - Hallux Valgus and Bunion, Sedation | Phase 2 | Unknown | Asklepieion Voulas General Hospital | 60 | 2020-01-29 | 2020-01-30 |
| A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation HSK3486 0.1-0.2 /0.3 mg / kg group, Propofol 0.5-1.0/1.5 mg/kg group - Sedation | Phase 2 | Completed | Sichuan Haisco Pharmaceutical Group Co., Ltd | 39 | 2019-11-22 | 2022-05-27 |
| Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam Propofol, Midazolam - Sedation, Endoscopy | Phase 2 | Completed | DongGuk University | 30 | 2018-10-19 | 2020-12-29 |
| Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients 0.2-0.7 mcg/kg/h dexmedetomedine infusion., 10-70 mcg/kg/h propofol infusion. - Sedation | Phase 2 / Phase 3 | Suspended | Assiut University | 60 | 2017-09-14 | 2020-07-14 |
| Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine. OTM Dexmedetomidine 1µg/ kg., OTM Dexmedetomidine 0.75µg/ kg., OTM Dexmedetomidine 0.5µg/ kg. - Sedation | Phase 2 / Phase 3 | Completed | Assiut University | 36 | 2017-04-05 | 2019-08-01 |
| Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure Dexmedetomidine 0.35µg/kg /h, Dexmedetomidine 0.5µg/kg /h - Sedation | Phase 2 / Phase 3 | Completed | Assiut University | 40 | 2016-12-01 | 2018-07-03 |
| A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy Remimazolam Tosilate, Propofol - Sedation | Phase 2 | Completed | Jiangsu HengRui Medicine Co., Ltd. | 153 | 2016-11-01 | 2017-09-08 |
| Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months Dexmedetomidine - Sedation, Pain | Phase 2 | Completed | Hospira, now a wholly owned subsidiary of Pfizer | 5 | 2011-06-01 | 2015-07-24 |
| Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age Midazolam, Fentanyl/Morphine, Dexmedetomidine - Sedation | Phase 2 / Phase 3 | Completed | Hospira, now a wholly owned subsidiary of Pfizer | 36 | 2010-07-01 | 2015-08-13 |
| Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy A. CNS 7056, B. CNS 7056, C. CNS 7056 - Sedation | Phase 2 | Completed | Paion UK Ltd. | 162 | 2010-05-01 | 2019-01-08 |
| A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03), Placebo NanoTab™ - Sedation, Anxiety | Phase 2 | Completed | Talphera, Inc | 40 | 2009-06-01 | 2014-06-25 |
| Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients Dexmedetomidine - Burns, Sedation | Phase 2 | Completed | Massachusetts General Hospital | 8 | 2007-07-16 | 2017-07-17 |
| Acute Neurological ICU Sedation Trial (ANIST) Fentanyl/Dexmedetomidine, Fentanyl/Propofol, Fentanyl - Sedation | Phase 2 | Completed | Johns Hopkins University | 35 | 2005-05-01 | 2019-05-16 |
| Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers Remifentanil+clonidine - Acute Pain, Respiration | Phase 1 / Phase 2 | Completed | Oslo University Hospital | 12 | 2005-02-01 | 2011-07-06 |
Anxiety Disorders (2) · Pain (2) · Acute Pain (1) · Agnosia (1) · Autism Spectrum Disorder (1) · Bunion (1) · Burns (1) · Hallux Valgus (1) · Respiratory Aspiration (1)
Neurologic Manifestations (4) · Pathological Conditions, Signs and Symptoms (4) · Signs and Symptoms (4) · Mental Disorders (3) · Child Development Disorders, Pervasive (1) · Foot Deformities (1) · Foot Deformities, Acquired (1) · Musculoskeletal Diseases (1) · Nervous System Diseases (1) · Neurobehavioral Manifestations (1) · Neurodevelopmental Disorders (1) · Pain (1) · Pathologic Processes (1) · Perceptual Disorders (1) · Respiration Disorders (1)
Dexmedetomidine (10) · Midazolam (3) · Propofol (3) · Fentanyl (2) · Remifentanil (2) · Clonidine (1) · Esketamine (1) · Geritol (1) · Morphine (1) · Pregabalin (1) · remimazolam (1)
Assiut University (4) · Hospira, now a wholly owned subsidiary of Pfizer (2) · Asklepieion Voulas General Hospital (1) · DongGuk University (1) · Jiangsu HengRui Medicine Co., Ltd. (1) · Johns Hopkins University (1) · Liaquat National Hospital & Medical College (1) · Massachusetts General Hospital (1) · Maternal and Child Health Hospital of Hubei Province (1) · Oslo University Hospital (1) · Paion UK Ltd. (1) · Sichuan Haisco Pharmaceutical Group Co., Ltd (1) · Talphera, Inc (1) · Zagazig University (1)
United States (6) · Egypt (5) · China (3) · Greece (1) · Guatemala (1) · Norway (1) · South Korea (1)
Hala S Abdelghaffar, MD (2) · Constantinos Chrysostomou, MD (1) · Erik S Shank, MD (1) · Hala S Abdel-Ghaffar, MD (1) · Jon B Bergmann, Ass. Prof. (1) · Linli Yue, MD (1) · Marek Mirski, MD, PhD (1) · Pamela Palmer, M.D., PhD (1) · Saher A Mohamed, MD (1) · Sara Abdel Naby, M.D (1)
PMID 15460178, PMID 21926576, PMID 24238862, PMID 24893689, PMID 26363333, PMID 32889844, PMID 34924506, PMID 39455495