Clinical trial NCT03996577: Intravenous Infusion of Lidocaine in ERCP
Official title: Efficacy of Intravenous Infusion of Lidocaine in Sedation for ERCP: a Randomised Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sedation
Keywords: lidocaine propofol ercp
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:Inpatients aged \>18 years who were scheduled for ERCP at Qilu hospital.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: propofol consumption difference between the two groups
timeFrame: half a year
Secondary outcomes:
measure: Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of hypotention during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of breadycardia during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of required airway management during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of involuntary movement during the procedure
timeFrame: half a year
measure: endoscopists satisfaction assessed by the performer
timeFrame: half a year
measure: patient satisfaction assessed by the patient
timeFrame: half a year
measure: pain socre after the ERCP
timeFrame: half a year
measure: fatigue score after the ERCP
timeFrame: half a year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
Study officials:
affiliation: Qilu Hospital of Shandong University
name: yanqing li
role: STUDY_CHAIR
References:
citation: 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.