Intravenous Lidocaine to Reduce ED50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy
NCT ID: NCT06143410
Last Updated: 2024-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-08
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations
NCT01127438
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
NCT01308541
Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
NCT02038894
Remifentanil Versus Propofol for TCI Sedation of Patients Undergoing Gastrointestinal Endoscopic Procedures
NCT01746641
Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation
NCT03196479
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Linisol
Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction
Lidocaine 2% Injectable Solution
administration of a bolus of lidocaine 1.5 mg/kg
Propofol injection
Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)
gastroscopy
esogastroduodenoscopy
Control
Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction
Saline administration as placebo
administration of a bolus of saline solution as a placebo
Propofol injection
Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)
gastroscopy
esogastroduodenoscopy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lidocaine 2% Injectable Solution
administration of a bolus of lidocaine 1.5 mg/kg
Saline administration as placebo
administration of a bolus of saline solution as a placebo
Propofol injection
Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)
gastroscopy
esogastroduodenoscopy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ASA score: 1 and 2
* BMI between 18 and 30 kg/m2
Exclusion Criteria
* Anesthesia within the last 7 days
* Use of local anesthesia in the last 24 hours
* Rhythm disorder or HR \<50
* Pregnant women and breastfeeding
* Participation in another clinical study in the last months
* Cannot understand VAS score or French
* Severe central nervous disease and mental illness.
* Obstructive sleep apnea (known or STOP BANG score \>5)
* Upper lung infection.
* Liver or kidney function disorder
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Erasme University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Céline Boudart, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasme hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boudart Céline
Brussels, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SRB2023309
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.