Diagnostic GastroscopyNCT05944887
Intravenous Lidocaine to Reduce Propofol Consumption 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 clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation 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
- 46 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jul 2023to 25 Aug 2023
- 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.
About this study
Official title: Does Intravenous Lidocaine Reduce Propofol Consumption and the Side Effects of Sedation During Gastroscopy in ASA 1 and 2 Patients.
The goal of this clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation 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.
After the gastroscopy, patients will be asked to complete a satisfaction questionnaire
- 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
administration of a bolus of saline solution as a placebo
Propofol injectionDrug
Sedation by total intravenous administration (TIVA) of propofol
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 |
| Sham | 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.
total propofol dose in milligramme
total propofol dose consumed
Measured: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)
total propofol dose in milligramme
total propofol dose consumed
Measured: Procedure (from the beginning of propofol infusion until endoscope removal)
propofol in site effet concentration in microgram per milliliter
AIVOC : Effect concentration of propofol
Measured: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)
propofol in site effet concentration in microgram per milliliter
AIVOC : Effect concentration of propofol
Measured: Procedure (from the beginning of propofol infusion until endoscope removal)
Secondary outcomes (10)
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 with severe hypoxemia
pulse saturation below 90%
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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start21 Jul 2023
- Primary completion21 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Assam, Erasme University Hospital
- Investigators
- celine Boudart, MD PhD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944887
- Sponsor's protocol ID
- P2023/236
- Status last verified
- Sep 2023
- First submitted
- 19 Jun 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Qi XR, Sun JY, An LX, Zhang K, Xue FS. Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial. Trials. 2022 Sep 24;23(1):800. doi: 10.1186/s13063-022-06719-6.
PubMed 36153625Qi XR, Sun JY, An LX, Zhang K. Effect of intravenous lidocaine on the ED50 of propofol for inserting gastroscope without body movement in adult patients: a randomized, controlled study. BMC Anesthesiol. 2022 Oct 17;22(1):319. doi: 10.1186/s12871-022-01861-9.
PubMed 36253717Hu S, Wang M, Li S, Zhou W, Zhang Y, Shi H, Ye P, Sun J, Liu F, Zhang W, Zheng L, Hou Q, Wang Y, Sun W, Chen Y, Lu Z, Ji Z, Liao L, Lv X, Wang Y, Wang X, Yang H. Intravenous Lidocaine Significantly Reduces the Propofol Dose in Elderly Patients Undergoing Gastroscopy: A Randomized Controlled Trial. Drug Des Devel Ther. 2022 Aug 12;16:2695-2705. doi: 10.2147/DDDT.S377237. eCollection 2022.
PubMed 35983429
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intravenous Lidocaine Reduce Propofol Consumption and the Side Effects of Sedation During Gastroscopy in ASA 1 and 2 Patients.
- ClinicalTrials.gov ID
- NCT05944887
- Acronym / sponsor ID
- P2023/236
- Conditions
- Diagnostic Gastroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 13 Jul 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 clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation 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.
After the gastroscopy, patients will be asked to complete a satisfaction questionnaire
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 |
| Sham | 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 placeboadministration of a bolus of saline solution as a placebo | Drug | Sham |
| Propofol injectionSedation by total intravenous administration (TIVA) of propofol | Drug | Linisol, Sham |
| gastroscopyesogastroduodenoscopy | Procedure or surgery | Linisol, Sham |
Primary outcome
total propofol dose in milligramme
Time frame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)
total propofol dose consumed
total propofol dose in milligramme
Time frame: Procedure (from the beginning of propofol infusion until endoscope removal)
total propofol dose consumed
propofol in site effet concentration in microgram per milliliter
Time frame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)
AIVOC : Effect concentration of propofol
propofol in site effet concentration in microgram per milliliter
Time frame: Procedure (from the beginning of propofol infusion until endoscope removal)
AIVOC : Effect concentration of propofol
10 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 with severe hypoxemia
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: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Background: PubMed 36153625Qi XR, Sun JY, An LX, Zhang K, Xue FS. Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial. Trials. 2022 Sep 24;23(1):800. doi: 10.1186/s13063-022-06719-6.
- Background: PubMed 36253717Qi XR, Sun JY, An LX, Zhang K. Effect of intravenous lidocaine on the ED50 of propofol for inserting gastroscope without body movement in adult patients: a randomized, controlled study. BMC Anesthesiol. 2022 Oct 17;22(1):319. doi: 10.1186/s12871-022-01861-9.
- Background: PubMed 35983429Hu S, Wang M, Li S, Zhou W, Zhang Y, Shi H, Ye P, Sun J, Liu F, Zhang W, Zheng L, Hou Q, Wang Y, Sun W, Chen Y, Lu Z, Ji Z, Liao L, Lv X, Wang Y, Wang X, Yang H. Intravenous Lidocaine Significantly Reduces the Propofol Dose in Elderly Patients Undergoing Gastroscopy: A Randomized Controlled Trial. Drug Des Devel Ther. 2022 Aug 12;16:2695-2705. doi: 10.2147/DDDT.S377237. eCollection 2022.
- Individual participant dataSharing planned: Yes
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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.
celine Boudart, MD 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: finished, as of the sponsor's last update on 18 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total propofol dose in milligramme (time frame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944887, which also lists 3 linked publications.
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 18 Sep 2023.