Intravenous Infusion of Lidocaine in ERCP

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Sedation

Treatments: Drug: placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03996577

2019SDU-QILU-071

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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;

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

the control group will be given the same volume of saline as the experimental group

Treatment:

Drug: placebo

Experimental: lidocaine group

Experimental group

Description:

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

Treatment:

Drug: Lidocaine