Intravenous Infusion of Lidocaine in ERCP

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

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

Study Overview

• Status: Unknown
• Conditions: Sedation
• Intervention / Treatment: Drug: placebo; Drug: Lidocaine

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: jing liu; Phone Number: +86-18560083755; Email: liujing2013@126.com

Study Locations

• China
  • Jinan, China
    • Recruiting
    • Qilu Hospital of Shandong University
    • Contact: Yanqing Li
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 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 involuntary movement during the procedure	Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure	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
fatigue score after the ERCP	fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later	half a year
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
pain socre after the ERCP	pain were measured on a 0-10VAS at arrival in the recovery room ,30min later	half a year

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Study Chair: Yanqing Li, Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): October 15, 2019
• Study Completion (Anticipated): November 15, 2019

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: lidocaine propofol ercp
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2019SDU-QILU-071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No