Intravenous Infusion of Lidocaine in ERCP

Shandong University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Sedation

Interventions

LidocaineDRUG

the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h

placeboDRUG

the control group will be given the same volume of saline.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (2)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, China

RECRUITING

Outcomes

Primary Outcomes

propofol consumption difference between the two groups

the total propofol dosage consumption between the two groups

Time frame: half a year

Secondary Outcomes

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

Time frame: half a year

Safety assessed by the rate of hypotention during the procedure

Hypotension, defined as systolic blood pressure \<90 mmHg

Time frame: half a year

Safety assessed by the rate of breadycardia during the procedure

Bradycardia, defined as heart rate \<50 beats/min

Time frame: 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

Time frame: 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

Time frame: half a year

endoscopists satisfaction assessed by the performer

the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure

Central Contacts

jing liu

CONTACT

+86-18560083755 liujing2013@126.com

Data from ClinicalTrials.gov

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