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Sedation clinical trials

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NCT ID: NCT04147416 Completed - Sedation Clinical Trials

A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation

Start date: November 22, 2019
Phase: Phase 2
Study type: Interventional

This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.

NCT ID: NCT04145583 Completed - Anesthesia Clinical Trials

A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets

Start date: December 14, 2019
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, randomized, two-stage, two-way crossover study evaluating the effect of voriconazole on the PK, PD, and safety of HSK3486 in healthy subjects.

NCT ID: NCT04096768 Recruiting - Sedation Clinical Trials

The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

Start date: September 16, 2019
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the use of dexmedetomidine + ketamine with dexmedetomidine + placebo for sedation in ICU patients in terms of safety and efficacy

NCT ID: NCT04075006 Completed - Critical Illness Clinical Trials

Analgosedative adjuncT keTAmine Infusion iN Mechanically vENTilated ICU Patients

ATTAINMENT
Start date: August 28, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of a low dose ketamine infusion used in combination of standard of care in critically ill patients to test whether ketamine can help to shorten the time of being in breathing tube and ventilator compared to the standard of care alone.

NCT ID: NCT04072328 Completed - Sedation Clinical Trials

Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam

Start date: October 19, 2018
Phase: Phase 2
Study type: Interventional

This study is to compare propofol vs. midazolam with propofol for sedative endoscopy in patients with previous paradoxical reaction to midazolam. Patients who meet eligibility criteria will randomly assigned to propofol group or midazolam with propofol group. Then they will receive a sedative endoscopy with close monitoring. The primary outcome is the prevalence of paradoxical response during endoscopy.

NCT ID: NCT04054063 Completed - Sedation Clinical Trials

A Study Evaluating Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 and Etomidate for Induction of Anesthesia in Healthy Male Subjects

Start date: November 30, 2016
Phase: Phase 1
Study type: Interventional

This study is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of the 2 drugs and the safety profile including pain on injection, hypotension, tachycardia or bradycardia effects (HSK3486), and involuntary muscle movements, nausea and vomiting potential and adrenal suppression (etomidate). All subjects will be administered HSK3486 plus etomidate. Subjects will be confined to the study unit from the evening of Day -1 until the morning of Day 2, then will be required to return for a follow up visit on Day 7. Intensive PD, PK, safety and tolerability and assessments will be performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

NCT ID: NCT04040439 Completed - Sedation Clinical Trials

Precedex Special Investigation (in Pediatric Patients)

Start date: July 30, 2019
Phase:
Study type: Observational

Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

NCT ID: NCT04037657 Completed - Anesthesia Clinical Trials

Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Female Subjects.

Start date: April 22, 2015
Phase: Phase 1
Study type: Interventional

This study was a single-center positive-controlled, randomized, dose-escalation study of HSK3486 in healthy female subjects administered as a single IV bolus dose.Subjects were confined to the study unit from the evening of Day -1 until the morning of Day 2, then were required to return for a follow up visit on Day 5. Intensive safety, PD and PK assessments were performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

NCT ID: NCT04033939 Completed - Anesthesia Clinical Trials

A Study Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Subjects.

Start date: April 13, 2014
Phase: Phase 1
Study type: Interventional

This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486 administered as a single IV injection. Results from this study will supports further clinical development of HSK3486. This study will be performed in compliance with the protocol, International Conference on Harmonization Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study concerned with the investigational product will meet the requirements of Good Manufacturing Practice (GMP).

NCT ID: NCT04029766 Completed - Anesthesia Clinical Trials

A Study Evaluating Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of HSK3486 Single Bolus Dose Followed With a 30 Minute Constant Infusion in Healthy Male Subjects

Start date: November 10, 2015
Phase: Phase 1
Study type: Interventional

This study was a single center, open-label, single dose escalation study in healthy male subjects to investigate a bolus dose followed by a 30 minute constant infusion of HSK3486 over two cohorts.