Intravenous Infusion of Lidocaine in Gastroscopy

Study Overview
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Brief Summary
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Intravenous infusion of lidocaine significantly reduces incidence of bucking when perfomed gastroscopy.

Detailed Description
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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.

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: placebo
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged >18 years who were scheduled for ERCP at Qilu hospital. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: 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 |
| --- | --- | --- |
| the incidence of bucking during the procedure | the difference between incidence of bucking of the two groups | half a year | 

Secondary 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 | 
| the incidence of infusion pain when adminstrated propofol | the infusion pain devied into no pain, mild pian, and severe pain | half a year | 
| 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 | 
| 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 | 
| anesthetist satisfaction | the anesthetist satisfacition score were assessed on a 0-10VAS 30mins after the procedure | half a year | 
| pain socre after the gastroscopy | 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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intravenous lidocaine gastroscopy bucking