SedationPhase 4NCT03996577
Intravenous Infusion of Lidocaine in ERCP
A Phase 4 study testing Lidocaine in people with Sedation, run by Shandong University at 2 sites in China.
Trial summary
Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- 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
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 15 May 2019to 15 Nov 2019
- Phase
- Phase 4
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with ASA class 4 or 5,
- Patients with pre-existing hypoxaemia (SpO2<90%),
- Patients with hypotension (SBP<90mmHg)
- Patients with bradycardia (HR<50 bpm)
- patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
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- patients with pregnancy or lactation
- Patients hemodynamically unstable
- Patients unable to give informed consent
- Patients with a history of drug allergies;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PHD, 86-531-82169236, liyanqing@sdu.edu.cn
- Recruiting
Qilu Hospital of Shandong University
Jinan
yanqing li
About this study
Official title: Efficacy of Intravenous Infusion of Lidocaine in Sedation for ERCP: a Randomised Placebo-controlled Study
Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP.
Read the detailed description
This study divide patients into two groups, one will be given lidocaine; another group was given placebo . to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Compound Lidocaine Hydrochloride Injiection
the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
placeboDrug
Also called saline
the control group will be given the same volume of saline.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | the control group will be given the same volume of saline as the experimental group Receives: Drug: placebo |
| Experimental: lidocaine group | Experimental | 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 difference between the two groups
the total propofol dosage consumption between the two groups
Measured: half a year
Secondary outcomes (9)
Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure
Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds
Measured: half a year
Safety assessed by the rate of hypotention during the procedure
Hypotension, defined as systolic blood pressure <90 mmHg
Measured: half a year
Safety assessed by the rate of breadycardia during the procedure
Bradycardia, defined as heart rate <50 beats/min
Measured: half a year
Safety assessed by the rate of required airway management during the procedure
Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia
Measured: half a year
Safety assessed by the rate of involuntary movement during the procedure
Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure
Measured: half a year
endoscopists satisfaction assessed by the performer
the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure
Measured: half a year
patient satisfaction assessed by the patient
the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure
Measured: half a year
pain socre after the ERCP
pain were measured on a 0-10VAS at arrival in the recovery room ,30min later
Measured: half a year
fatigue score after the ERCP
fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start15 May 2019
- Primary completion15 Oct 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Health services research
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- yanqing li, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996577
- Sponsor's protocol ID
- 2019SDU-QILU-071
- Status last verified
- Sep 2019
- First submitted
- 18 Jun 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu J, Liu X, Peng LP, Ji R, Liu C, Li YQ. Efficacy and safety of intravenous lidocaine in propofol-based sedation for ERCP procedures: a prospective, randomized, double-blinded, controlled trial. Gastrointest Endosc. 2020 Aug;92(2):293-300. doi: 10.1016/j.gie.2020.02.050. Epub 2020 Mar 7.
PubMed 32156544
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Infusion of Lidocaine in Sedation for ERCP: a Randomised Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03996577
- Acronym / sponsor ID
- 2019SDU-QILU-071
- Conditions
- Sedation
- Keywords
- lidocaine propofol ercp
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 25 Jun 2019 (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.
Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP.
Detailed description
This study divide patients into two groups, one will be given lidocaine; another group was given placebo . to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.
Study design
- Primary purpose
- Health services research
- 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 |
|---|---|---|
| control group | Placebo comparator | Drug: placebothe control group will be given the same volume of saline as the experimental group |
| Experimental: lidocaine group | Experimental | Drug: Lidocainethe experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Patients with ASA class 4 or 5,
- Patients with pre-existing hypoxaemia (SpO2<90%),
- Patients with hypotension (SBP<90mmHg)
- Patients with bradycardia (HR<50 bpm)
- patients with severe chronic renal failure (creatinine clearance<30 ml/min)
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 |
|---|---|---|
| LidocaineAlso: Compound Lidocaine Hydrochloride Injiectionthe experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h | Drug | Experimental: lidocaine group |
| placeboAlso: salinethe control group will be given the same volume of saline. | Drug | control group |
Primary outcome
propofol consumption difference between the two groups
Time frame: half a year
the total propofol dosage consumption between the two groups
9 secondary outcomes
Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure
Time frame: half a year
Safety assessed by the rate of hypotention during the procedure
Time frame: half a year
Safety assessed by the rate of breadycardia during the procedure
Time frame: half a year
Safety assessed by the rate of required airway management during the procedure
Time frame: half a year
Safety assessed by the rate of involuntary movement during the procedure
Time frame: half a year
endoscopists satisfaction assessed by the performer
Time frame: half a year
patient satisfaction assessed by the patient
Time frame: half a year
pain socre after the ERCP
Time frame: half a year
fatigue score after the ERCP
Time frame: half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Derived from this study: PubMed 32156544Liu J, Liu X, Peng LP, Ji R, Liu C, Li YQ. Efficacy and safety of intravenous lidocaine in propofol-based sedation for ERCP procedures: a prospective, randomized, double-blinded, controlled trial. Gastrointest Endosc. 2020 Aug;92(2):293-300. doi: 10.1016/j.gie.2020.02.050. Epub 2020 Mar 7.
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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.
yanqing li study chair
Qilu Hospital of Shandong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Sedation, run by Shandong University at 2 sites in China.
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 0 inclusion and 10 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 jing liu (+86-18560083755, liujing2013@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
propofol consumption difference between the two groups (time frame: half a year). 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 NCT03996577, which also lists 1 linked publication.
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 23 Sep 2019.