SedationPhase 4NCT04439773
Intravenous Infusion of Lidocaine in Gastroscopy
A Phase 4 study testing Lidocaine in people with Sedation, run by Shandong University at 1 site in China.
Trial summary
Intravenous infusion of lidocaine significantly reduces incidence of bucking when perfomed gastroscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Dec 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged >18 years who were scheduled for ERCP at Qilu hospital.
Who cannot join
- patients with ASA (American Society of Anesthesiologists) Class 4 or 5, pre-existing hypoxemia (SpO2 <90%), hypotension (systolic blood pressure <90 mm Hg), bradycardia (HR<50 beats/min), uncontrolled hypertension (SBP >170 mm Hg, diastolic blood pressure>100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to lidocaine, atrioventricular block, epilepsy, and inability to give informed consen
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
jinan shandong
Yanqing li, 86-531-82169236, liyanqing@sdu.edu.cn
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 incidence of bucking when perfomed gastroscopy.
Read the detailed description
This study divide patients into two groups, the patients in lidocaine group will be given lidocaine; the control group will be given placebo .the primary endopiont was to investigate whether intravenous lidocaine can reduce incidence of bucking and movement in sedation of gastroscopy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called saline
the control group will be given the same volume of saline.
LidocaineDrug
Also called Compound Lidocaine Hydrochloride Injiection
the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
| 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 |
| 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.
the incidence of bucking during the procedure
the difference between incidence of bucking of the two groups
Measured: half a year
Secondary outcomes (11)
propofol consumption difference between the two groups
the total propofol dosage consumption between the two groups
Measured: half a year
the incidence of infusion pain when adminstrated propofol
the infusion pain devied into no pain, mild pian, and severe pain
Measured: half a year
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
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
anesthetist satisfaction
the anesthetist satisfacition score were assessed on a 0-10VAS 30mins after the procedure
Measured: half a year
pain socre after the gastroscopy
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 posted19 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Shan dong China, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439773
- Sponsor's protocol ID
- 2020SDU-QILU-022
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. 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
- NCT04439773
- Acronym / sponsor ID
- 2020SDU-QILU-022
- Conditions
- Sedation
- Keywords
- intravenous lidocaine gastroscopy bucking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Jun 2020 (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 incidence of bucking when perfomed gastroscopy.
Detailed description
This study divide patients into two groups, the patients in lidocaine group will be given lidocaine; the control group will be given placebo .the primary endopiont was to investigate whether intravenous lidocaine can reduce incidence of bucking and movement in sedation of gastroscopy.
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 |
| 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 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged >18 years who were scheduled for ERCP at Qilu hospital.
Key exclusion criteria (1 listed)
- patients with ASA (American Society of Anesthesiologists) Class 4 or 5, pre-existing hypoxemia (SpO2 <90%), hypotension (systolic blood pressure <90 mm Hg), bradycardia (HR<50 beats/min), uncontrolled hypertension (SBP >170 mm Hg, diastolic blood pressure>100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to lidocaine, atrioventricular block, epilepsy, and inability to give informed consen
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 |
|---|---|---|
| placeboAlso: salinethe control group will be given the same volume of saline. | Drug | control group |
| LidocaineAlso: Compound Lidocaine Hydrochloride Injiectionthe experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h | Drug | lidocaine group |
Primary outcome
the incidence of bucking during the procedure
Time frame: half a year
the difference between incidence of bucking of the two groups
11 secondary outcomes
propofol consumption difference between the two groups
Time frame: half a year
the incidence of infusion pain when adminstrated propofol
Time frame: half a year
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
endoscopists satisfaction assessed by the performer
Time frame: half a year
patient satisfaction assessed by the patient
Time frame: half a year
anesthetist satisfaction
Time frame: half a year
pain socre after the gastroscopy
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 19 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Shan dong China study chair
Qilu Hospital of Shandong University
1 site 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 1 site 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 1 inclusion and 1 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 19 Jun 2020. 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 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, liujingqilu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of bucking during the procedure (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?
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 19 Jun 2020.