Intravenous Infusion of Lidocaine in ERCP

Study Overview
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Brief Summary
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Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP.

Detailed Description
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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.

Official Title
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Efficacy of Intravenous Infusion of Lidocaine in Sedation for ERCP: a Randomised Placebo-controlled Study

Conditions
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Sedation

Intervention / Treatment
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* Drug: Lidocaine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>the control group will be given the same volume of saline as the experimental group | Drug: placebo<br>* the control group will be given the same volume of saline.<br>* Other names: saline;|
| Experimental: Experimental: lidocaine group<br>the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h | Drug: Lidocaine<br>* the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h<br>* Other names: Compound Lidocaine Hydrochloride Injiection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol consumption difference between the two groups | the total propofol dosage consumption between the two groups | half a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | half a year | 
| Safety assessed by the rate of hypotention during the procedure | Hypotension, defined as systolic blood pressure <90 mmHg | half a year | 
| Safety assessed by the rate of breadycardia during the procedure | Bradycardia, defined as heart rate <50 beats/min | 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 | 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 | half a year | 
| endoscopists satisfaction assessed by the performer | the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure | half a year | 
| patient satisfaction assessed by the patient | the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure | half a year | 
| pain socre after the ERCP | pain were measured on a 0-10VAS at arrival in the recovery room ,30min later | half a year | 
| fatigue score after the ERCP | fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later | half a year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine propofol ercp