Intravenous Infusion of Lidocaine in ERCP
Efficacy of Intravenous Infusion of Lidocaine in Sedation for ERCP: a Randomised Placebo-controlled Study
1 other identifier
interventional
40
1 country
2
Brief Summary
Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2019
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2019
CompletedSeptember 23, 2019
September 1, 2019
5 months
June 18, 2019
September 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
propofol consumption difference between the two groups
the total propofol dosage consumption between the two groups
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
half a year
Safety assessed by the rate of hypotention during the procedure
half a year
Safety assessed by the rate of breadycardia during the procedure
half a year
Safety assessed by the rate of required airway management during the procedure
half a year
Safety assessed by the rate of involuntary movement during the procedure
half a year
- +4 more secondary outcomes
Study Arms (2)
control group
PLACEBO COMPARATORthe control group will be given the same volume of saline as the experimental group
Experimental: lidocaine group
EXPERIMENTALthe experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h
Interventions
Eligibility Criteria
You may not qualify if:
- 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)
- patients with pregnancy or lactation
- Patients hemodynamically unstable
- Patients unable to give informed consent
- Patients with a history of drug allergies;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Qilu Hospital of Shandong University
Jinan, China
Related Publications (1)
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.
PMID: 32156544DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
yanqing li
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Qilu Hospital
Study Record Dates
First Submitted
June 18, 2019
First Posted
June 25, 2019
Study Start
May 15, 2019
Primary Completion
October 15, 2019
Study Completion
November 15, 2019
Last Updated
September 23, 2019
Record last verified: 2019-09