Clinical Trials Logo
  1. Home
  2. Sedation
  3. NCT04054063

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

Sedation Clinical Trial

Official title:
An Open Label, Single-Center, Single Dose Combination of HSK3486 and Etomidate Intravenous Bolus Injection to Determine the Safety, Pharmacodynamics and Pharmacokinetics for Induction of Anesthesia in Healthy Male Subjects

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04054063
Study type Interventional
Source Sichuan Haisco Pharmaceutical Group Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 30, 2016
Completion date June 28, 2017
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03399019 - Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia N/A
Completed NCT03220880 - Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Recruiting NCT04820205 - Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children N/A
Recruiting NCT04549623 - End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography N/A
Recruiting NCT04822064 - Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation N/A
Completed NCT01527903 - A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit Phase 4
Completed NCT01001533 - Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation N/A
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT00158873 - Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects Phase 4
Terminated NCT00205517 - Sedation and Psychopharmacology in Critical Care N/A
Recruiting NCT04096768 - The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation Phase 3
Active, not recruiting NCT05082623 - The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters N/A
Suspended NCT03285165 - Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients Phase 2/Phase 3
Active, not recruiting NCT04788589 - Sedation and Ventilator Weaning Protocol in PICU N/A
Completed NCT03425474 - Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy Phase 3
Recruiting NCT06061159 - The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction Phase 4
Completed NCT06449365 - Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy Phase 4
Completed NCT02171910 - Doxapram as an Additive to Propofol Sedation in Sedation for ERCP Phase 4
Completed NCT02211118 - Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD Phase 4
Completed NCT01694745 - EUROpean Pain Audit In Neonates N/A