Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Infusion of Lidocaine in ERCP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996577
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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

Condition or disease Intervention/treatment Phase
Sedation Drug: Lidocaine Drug: placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Efficacy of Intravenous Infusion of Lidocaine in Sedation for ERCP: a Randomised Placebo-controlled Study
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Compound Lidocaine Hydrochloride Injiection




Primary Outcome Measures :
  1. propofol consumption difference between the two groups [ Time Frame: half a year ]
    the total propofol dosage consumption between the two groups


Secondary Outcome Measures :
  1. Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure [ Time Frame: half a year ]
    Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds

  2. Safety assessed by the rate of hypotention during the procedure [ Time Frame: half a year ]
    Hypotension, defined as systolic blood pressure <90 mmHg

  3. Safety assessed by the rate of breadycardia during the procedure [ Time Frame: half a year ]
    Bradycardia, defined as heart rate <50 beats/min

  4. Safety assessed by the rate of required airway management during the procedure [ Time Frame: half a year ]
    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

  5. Safety assessed by the rate of involuntary movement during the procedure [ Time Frame: half a year ]
    Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure

  6. endoscopists satisfaction assessed by the performer [ Time Frame: half a year ]
    the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure

  7. patient satisfaction assessed by the patient [ Time Frame: half a year ]
    the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure

  8. pain socre after the ERCP [ Time Frame: half a year ]
    pain were measured on a 0-10VAS at arrival in the recovery room ,30min later

  9. fatigue score after the ERCP [ Time Frame: half a year ]
    fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996577


Contacts
Layout table for location contacts
Contact: jing liu +86-18560083755 liujing2013@126.com

Locations
Layout table for location information
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, PHD    86-531-82169236    liyanqing@sdu.edu.cn   
China
Qilu Hospital of Shandong University Recruiting
Jinan, China
Contact: yanqing li         
Sponsors and Collaborators
Shandong University
Investigators
Layout table for investigator information
Study Chair: yanqing li Qilu Hospital of Shandong University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT03996577    
Other Study ID Numbers: 2019SDU-QILU-071
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanqing Li, Shandong University:
lidocaine propofol ercp
Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action