SedationPhase 1NCT05274984
Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure
A Phase 1 study testing Lidocaine in people with Sedation, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Sedation
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 3 Jan 2022to 3 Apr 2022
- Phase
- Phase 1
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65-85 years old
- physical status ASA I, II, III,
- ERCP scheduled
Who cannot join
- ASA IV or higher
- severe renal, cardiac or liver failure,
- allergy to lidocaine,
- patients weighing less than 40 kg,
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Alex Alexandru, MD contact
Romania1 site, 1 recruiting
- Recruiting
Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"
Cluj-Napoca, Cluj, 400162
Caius M Breazu, MD, 0040743010012, csbreazu@yahoo.com
Caius M Breazu, MD
About this study
Official title: Lidocaine Continuous Infusion for ERCP Procedures: a Prospective, Randomized, Double-blinded, Controlled Trial
This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old.
Read the detailed description
The primary aim of this study was to evaluate the effect of continuous infusion of lidocaine on propofol consumption in older patients having ERCP sedation. Secondary outcomes were to evaluate patient adverse events, sedation quality and satisfaction of the patient and the endoscopist, postprocedural pain, and sedation-related time.For this the investigators randomised patients into 2 groups: Group Lidocaine received 1,5 mg/kg lidocaine 1% 10 min before procedure and then 2 mg/kg/h continuous infusion of lidocaine 1%, whereas the Group Control received an equal volume of saline solution, which could not be visually identified from lidocaine by the blinded anaesthesiologist. All patients received propofol bolus dose of 1mg/kg than 10-20 mg iv boluses during the procedure guided by capnograph monitoring and the patient's grimace, mobility, hemodynamic changes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
the control group will be given the same volume of saline.
LidocaineDrug
the experimental group will be given 1.5mg/kg lidocaine and then 2mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Group Placebo | Placebo comparator | the control group will be given the same volume of saline as the experimental group Receives: Drug: Placebo |
| Group Lidocaine | Active comparator | the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol consumption between the 2 groups
To evaluate propofol consumption by recording total dose of propofol(mg) during ERCP procedure between the 2 groups.
Measured: During ERCP procedure
Secondary outcomes (4)
Safety assessed by the rate of hypoxia during the procedure
Recording the number of hypoxia episodes, defined as peripheral oxygen saturation <94% for >30 seconds during ERCP procedure between the 2 groups.
Measured: During ERCP procedure
Safety assessed by the rate of involuntary movement during the procedure
Number of involuntary movements, defined as unconscious movements requiring restraint of patients during ERCP procedure between the 2 groups
Measured: During ERCP procedure
Lidocaine
Asses the total dose of lidocaine (mg) used in GROUP Lidocaine during ERCP procedure
Measured: During ERCP procedure
Endoscopist satisfaction between 2 groups
The endoscopists satisfaction score to be assessed on a 1-4 VAS after the procedure ( 1-poor, 2-moderate, 3-good, 4-excellent)
Measured: After ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start3 Jan 2022
- Primary completion3 Mar 2022 (estimated)
- Study completion3 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to controll group or lidocaine group. Participants of control group are given placebo while participants of lidocaine group are given lidocaine.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breazu Caius Mihai, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Daniela Ionescu, MD PhD, Study chair, UMF Iuliu Hatieganu Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274984
- Sponsor's protocol ID
- LIP
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Continuous Infusion for ERCP Procedures: a Prospective, Randomized, Double-blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT05274984
- Acronym / sponsor ID
- LIP
- Conditions
- Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 3 Mar 2022 (estimated)
- Study completion
- 3 Apr 2022 (estimated)
- First posted
- 11 Mar 2022 (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.
This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old.
Detailed description
The primary aim of this study was to evaluate the effect of continuous infusion of lidocaine on propofol consumption in older patients having ERCP sedation. Secondary outcomes were to evaluate patient adverse events, sedation quality and satisfaction of the patient and the endoscopist, postprocedural pain, and sedation-related time.For this the investigators randomised patients into 2 groups: Group Lidocaine received 1,5 mg/kg lidocaine 1% 10 min before procedure and then 2 mg/kg/h continuous infusion of lidocaine 1%, whereas the Group Control received an equal volume of saline solution, which could not be visually identified from lidocaine by the blinded anaesthesiologist. All patients received propofol bolus dose of 1mg/kg than 10-20 mg iv boluses during the procedure guided by capnograph monitoring and the patient's grimace, mobility, hemodynamic changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to controll group or lidocaine group. Participants of control group are given placebo while participants of lidocaine group are given lidocaine.
| Arm | Type | Receives |
|---|---|---|
| Group Placebo | Placebo comparator | Drug: Placebothe control group will be given the same volume of saline as the experimental group |
| Group Lidocaine | Active comparator | Drug: Lidocainethe experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65-85 years old
- physical status ASA I, II, III,
- ERCP scheduled
Key exclusion criteria (5 listed)
- ASA IV or higher
- severe renal, cardiac or liver failure,
- allergy to lidocaine,
- patients weighing less than 40 kg,
- inability to give informed consent
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 |
|---|---|---|
| Placebothe control group will be given the same volume of saline. | Drug | Group Placebo |
| Lidocainethe experimental group will be given 1.5mg/kg lidocaine and then 2mg/kg/h | Drug | Group Lidocaine |
Primary outcome
Propofol consumption between the 2 groups
Time frame: During ERCP procedure
To evaluate propofol consumption by recording total dose of propofol(mg) during ERCP procedure between the 2 groups.
4 secondary outcomes
Safety assessed by the rate of hypoxia during the procedure
Time frame: During ERCP procedure
Safety assessed by the rate of involuntary movement during the procedure
Time frame: During ERCP procedure
Lidocaine
Time frame: During ERCP procedure
Endoscopist satisfaction between 2 groups
Time frame: After ERCP procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Alex Alexandru, MD contact
Daniela Ionescu, MD PhD study chair
UMF Iuliu Hatieganu Cluj-Napoca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine in people with Sedation, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 5 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 11 Mar 2022. 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 Romania. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Caius Breazu, MD PHD (0040743010012, csbreazu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol consumption between the 2 groups (time frame: During ERCP procedure). 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 11 Mar 2022.