Clinical trials: Propofol
Anesthesia, Sedation
A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV…
- Trial name
- NCT03745625
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Airway Obstruction, Sedation Complication
Medical Device for Airway Patency During Sedation
OVERALL SYNOPSIS PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype…
- Conditions
- Airway Obstruction, Sedation Complication, Perioperative Complication
- Trial name
- STAIRWAY-2 (NCT06270212)
- Testing
- STAIRWAY, NO DEVICE
- Where
- Sweden
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Stairway Medical AB
Monitored Anesthesia Care
A Study to Characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of LUSEDRA® Administered as Continuous Infusion or Bolus Compared With Continuous Infusion of Propofol Injectable Emulsion
The purpose of this study is to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of LUSEDRA® administered as a continuous infusion or bolus compared with continuous infusion of propofol injectable emulsion.
- Trial name
- NCT01308541
- Testing
- arm 1, LUSEDRA, Propofol (arm 3)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
Bioequivalence Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese Subjects
This study assessed the bioequivalence and safety of a single dose of Propofol Medium/Long Chain Fat Emulsion Injection (Test product, Haisco Pharmaceutical Group Co., Ltd.) compared to the reference product (Propofol Medium/Long…
- Trial name
- NCT07057609
- Testing
- Tested Propofol Medium and Long Chain Fat Emulsion Injection (T), Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Airway Obstruction, Sedation Complication
Evaluation of Medical Device for Airway Patency During Sedation (SW01-2022)
The goal of this four-part preclinical [I-II] and clinical [III-IV] trial is to compare, with randomised crossover study design [I-IV], a new medical airway device with standard procedure (biteblock or no device) for upper airway…
- Conditions
- Airway Obstruction, Sedation Complication, Safety Issues, Patient Satisfaction
- Trial name
- NCT05708651
- Testing
- Investigational device [I-IV], Comparator [I-IV]
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Stairway Medical AB
Chronic Insomnia, Sleep Deprivation
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders.
- Conditions
- Chronic Insomnia, Sleep Deprivation, REM Behavior Disorder, REM Sleep Behavior Disorder
- Trial name
- PSHW (NCT06644573)
- Testing
- PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy, Diprivan (propofol), Astra-Zeneca
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Nyree Penn
Healthy Volunteers
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
This study is a randomized, double-blind, propofol position-controlled trial, evaluating the safety, tolerability, and pharmacodynamic of continuous infusion of KL0011034 injection compared with propofol injectable emulsion for…
- Trial name
- NCT07828470
- Testing
- KL0011034 injection, propofol injectable emulsion
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
Anesthesia
Perioperative Audio for Anaesthesia
Induction and emergence from propofol can be a difficult process for patients and healthcare workers, and long recovery times in particular can limit the rate of care.
- Trial name
- NCT05291832
- Testing
- Brain.fm Music, Spectrally-matched Noise
- Where
- United States
- Volunteers
- 329 people, healthy volunteers welcome
- Sponsor
- Brain.fm, Inc.
Anesthesia
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)
The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.
- Trial name
- SONORA (NCT04466384)
- Testing
- BIS
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
General Anesthesia
Exploratory Study of Propofol and Fentanyl Pharmacodynamics
Exploration of the hypothesis that general anesthesia is not a singular threshold but is a continuum of central nervous system depression dependent on interpretation of nociceptive stimuli.
- Trial name
- NCT01550770
- Testing
- propofol
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ethicon Endo-Surgery
Healthy Subjects
Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects
Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.
- Trial name
- NCT02713802
- Testing
- Cudafol(R) (propofol, 1% [10 mg/mL]), Diprivan(R) (propofol, 1% [10 mg/mL])
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Cuda Anesthetics, LLC
Anesthesia
A Study to Evaluate the Differences in Pharmadynamics, Pharmacokinetics, and Safety Between Ciprofol and Propofol
This is a single-center, open-label, randomized, two-stage, two-way crossover Phase I study in healthy male subjects.The main objective is to evaluate the differences in pharmadynamics (PD), pharmacokinetics (PK), and safety…
- Trial name
- NCT04294056
- Testing
- Ciprofol, Propofol
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Anesthesia
Improving Information Extraction From EEG on Cerebral Anesthetic Drug Effects
This is an interventional, randomized controlled study in health volunteers that involves collecting data on raw EEG waves measuring various combinations of anesthetic drugs during standardized drug titration.
- Trial name
- NCT02043938
- Testing
- SedLine EEG sensor
- Where
- Netherlands
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Anesthesia
Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery
This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.
- Trial name
- NCT04711837
- Testing
- HSK3486, Propofol
- Where
- 13 sites in United States
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Haisco-USA Pharmaceuticals, Inc.
General Anesthesia
Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous [IV] slow injection over 30 [±5] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to Propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection…
- Trial name
- NCT05486416
- Testing
- HSK3486, Propofol
- Where
- 28 sites in United States, Poland and 1 more
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Haisco-USA Pharmaceuticals, Inc.
Healthy
Detection of Propofol in Exhaled Breath
This study involves the use of an experimental device which will measure how much propofol is present in your exhaled breath during surgery compared to how much is in your blood.
- Trial name
- NCT02214394
- Testing
- High-performance liquid chromatography Analysis, SMART Device
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Xhale Assurance
General Anesthesia
Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous [IV] slow injection over 30 [±5] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection…
- Trial name
- NCT05478174
- Testing
- HSK3486, Propofol
- Where
- 23 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Haisco-USA Pharmaceuticals, Inc.
Anesthesia
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol.
- Trial name
- NCT01260142
- Testing
- Fospropofol disodium, propofol
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.