Diagnostic GastroscopyNCT06143410
Intravenous Lidocaine to Reduce ED50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy
A study testing Lidocaine 2% Injectable Solution, Propofol injection and gastroscopy in people with Diagnostic Gastroscopy, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The goal of this prospective, interventionnal clinical trial is to assess if intravenous administration of linisol reduce the ED50 of propofol when administered using Target Controlled Infusion (TCI) during gastroscopy in healthy patients (ASA 1 and 2 patients). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diagnostic Gastroscopy
- What is being tested?
- Lidocaine 2% Injectable Solution, Propofol injection and gastroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Apr 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for gastroscopy under narcosis and who have signed the consent.
- ASA score: 1 and 2
- BMI between 18 and 30 kg/m2
Who cannot join
- Lidocaine allergy
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Boudart Céline
Brussels, 1070
boudart céline, MD; PhD, +32484941133, celine.boudart@hubruxelles.be
About this study
Official title: Does Intravenous Lidocaine Reduce ED 50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy in ASA 1 and 2 Patients.
The goal of this prospective, interventionnal clinical trial is to assess if intravenous administration of linisol reduce the ED50 of propofol when administered using Target Controlled Infusion (TCI) during gastroscopy in healthy patients (ASA 1 and 2 patients).
Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.
- Conditions
- Diagnostic Gastroscopy
- Being tested
- Lidocaine 2% Injectable Solution, Saline administration as placebo, Propofol injection, gastroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% Injectable SolutionDrug
administration of a bolus of lidocaine 1.5 mg/kg
Saline administration as placeboDrug
Also called administration of a bolus of saline solution as a placebo
administration of a bolus of saline solution as a placebo
Propofol injectionDrug
Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)
gastroscopyProcedure or surgery
esogastroduodenoscopy
| Study group | Role | What they receive |
|---|---|---|
| Linisol | Active comparator | Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction Receives: Drug: Lidocaine 2% Injectable Solution; Drug: Propofol injection; Procedure: gastroscopy |
| Control | Placebo comparator | Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction Receives: Drug: Saline administration as placebo; Drug: Propofol injection; Procedure: gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED50 of propofol
ED50 of propofol for gastroscope introduction without movements
Measured: gastroscope introduction
Secondary outcomes (11)
number of participants with moderate hypoxemia
pulse saturation below 95%
Measured: Procedure (during propofol sedation and gastroscopy)
number of participants with hypotension
mean arterial pressure below 65 mmHg
Measured: Procedure (during propofol sedation and gastroscopy
number of participants presenting cough
cough suggesting to light sedation
Measured: Procedure (during propofol sedation and gastroscopy)
number of participants presenting laryngospasm
laryngospasm suggesting to light sedation
Measured: Procedure (during propofol sedation and gastroscopy)
number of participants presenting involuntary movements
involuntary movements suggesting to light sedation
Measured: Procedure (during propofol sedation and gastroscopy)
number of participants presenting side effects of lidocaine administration
metallic taste, tinnitus, anaphylaxis
Measured: Time Frame: during gastroscopy procedure
score of Endoscopist satisfaction (1-5)
Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent
Measured: completed procedure (before transfer to recovery room)
score of Patient satisfaction (1-5)
Patient satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent
Measured: at recovery room discharge, an average of 1 hour after completed procedure
throat pain
analog digital scale from 1 to 10
Measured: at recovery room discharge, an average of 1 hour after completed procedure
Time to anesthesia recover
Time between stopping Propofol and recovering a MOAA/S score ≥ 4
Measured: completed procedure (before transfer to recovery room)
Time for post anesthesic care unit discharge
Time between arrival and discharge of the post anesthesic care unit (Aldrette score >9)
Measured: at recovery room discharge, an average of 1 hour after completed procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start8 Apr 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic GastroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Boudart, PhD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143410
- Sponsor's protocol ID
- SRB2023309
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intravenous Lidocaine Reduce ED 50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy in ASA 1 and 2 Patients.
- ClinicalTrials.gov ID
- NCT06143410
- Acronym / sponsor ID
- SRB2023309
- Conditions
- Diagnostic Gastroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, interventionnal clinical trial is to assess if intravenous administration of linisol reduce the ED50 of propofol when administered using Target Controlled Infusion (TCI) during gastroscopy in healthy patients (ASA 1 and 2 patients).
Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linisol | Active comparator | Drug: Lidocaine 2% Injectable Solution, Drug: Propofol injection, Procedure: gastroscopyPatients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction |
| Control | Placebo comparator | Drug: Saline administration as placebo, Drug: Propofol injection, Procedure: gastroscopyPatients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for gastroscopy under narcosis and who have signed the consent.
- ASA score: 1 and 2
- BMI between 18 and 30 kg/m2
Key exclusion criteria (11 listed)
- Lidocaine allergy
- Anesthesia within the last 7 days
- Use of local anesthesia in the last 24 hours
- Rhythm disorder or HR <50
- Pregnant women and breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 2% Injectable Solutionadministration of a bolus of lidocaine 1.5 mg/kg | Drug | Linisol |
| Saline administration as placeboAlso: administration of a bolus of saline solution as a placeboadministration of a bolus of saline solution as a placebo | Drug | Control |
| Propofol injectionSedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI) | Drug | Control, Linisol |
| gastroscopyesogastroduodenoscopy | Procedure or surgery | Control, Linisol |
Primary outcome
ED50 of propofol
Time frame: gastroscope introduction
ED50 of propofol for gastroscope introduction without movements
11 secondary outcomes
number of participants with moderate hypoxemia
Time frame: Procedure (during propofol sedation and gastroscopy)
number of participants with hypotension
Time frame: Procedure (during propofol sedation and gastroscopy
number of participants presenting cough
Time frame: Procedure (during propofol sedation and gastroscopy)
number of participants presenting laryngospasm
Time frame: Procedure (during propofol sedation and gastroscopy)
number of participants presenting involuntary movements
Time frame: Procedure (during propofol sedation and gastroscopy)
number of participants presenting side effects of lidocaine administration
Time frame: Time Frame: during gastroscopy procedure
score of Endoscopist satisfaction (1-5)
Time frame: completed procedure (before transfer to recovery room)
score of Patient satisfaction (1-5)
Time frame: at recovery room discharge, an average of 1 hour after completed procedure
throat pain
Time frame: at recovery room discharge, an average of 1 hour after completed procedure
Time to anesthesia recover
Time frame: completed procedure (before transfer to recovery room)
Time for post anesthesic care unit discharge
Time frame: at recovery room discharge, an average of 1 hour after completed procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline Boudart, PhD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% Injectable Solution, Propofol injection and gastroscopy in people with Diagnostic Gastroscopy, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Céline Boudart, PhD (+322555391+9, celine.boudart@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED50 of propofol (time frame: gastroscope introduction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.