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Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | the control group will be given the same volume of saline as the experimental group |
|
| Experimental: lidocaine group | Experimental | the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h |
|
| Measure | Description | Time Frame |
|---|---|---|
| propofol consumption difference between the two groups | the total propofol dosage consumption between the two groups | half a year |
| 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 |
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Inclusion Criteria:Inpatients aged >18 years who were scheduled for ERCP at Qilu hospital.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jing liu | Contact | +86-18560083755 | liujing2013@126.com |
| Name | Affiliation | Role |
|---|---|---|
| yanqing li | Qilu Hospital of Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32156544 | Derived | 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. |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
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| placebo | Drug | the control group will be given the same volume of saline. |
|
|
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 |
| Qilu Hospital of Shandong University | Recruiting | Jinan | China |
|
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |