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 Gastroscopy

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: NCT04439773
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Brief Summary:
Intravenous infusion of lidocaine significantly reduces incidence of bucking when perfomed gastroscopy.

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

Detailed Description:
This study divide patients into two groups, the patients in lidocaine group will be given lidocaine; the control group will be given placebo .the primary endopiont was to investigate whether intravenous lidocaine can reduce incidence of bucking and movement in sedation of gastroscopy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 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
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020

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: 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. the incidence of bucking during the procedure [ Time Frame: half a year ]
    the difference between incidence of bucking of the two groups


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

  2. the incidence of infusion pain when adminstrated propofol [ Time Frame: half a year ]
    the infusion pain devied into no pain, mild pian, and severe pain

  3. 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

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

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

  6. 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

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

  8. 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

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

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

  11. 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 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

patients aged >18 years who were scheduled for ERCP at Qilu hospital.

Exclusion Criteria:

patients with ASA (American Society of Anesthesiologists) Class 4 or 5, pre-existing hypoxemia (SpO2 <90%), hypotension (systolic blood pressure <90 mm Hg), bradycardia (HR<50 beats/min), uncontrolled hypertension (SBP >170 mm Hg, diastolic blood pressure>100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to lidocaine, atrioventricular block, epilepsy, and inability to give informed consen


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): NCT04439773


Contacts
Layout table for location contacts
Contact: jing Liu +86-18560083755 liujingqilu@126.com
Contact: yanqing li 86-531-82169236 liyanqing@sdu.edu.cn

Locations
Layout table for location information
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: jinan shandong         
Contact: Yanqing li    86-531-82169236    liyanqing@sdu.edu.cn   
Sponsors and Collaborators
Shandong University
Investigators
Layout table for investigator information
Study Chair: Shan dong China Qilu Hospital of Shandong University
Layout table for additonal information
Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT04439773    
Other Study ID Numbers: 2020SDU-QILU-022
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
intravenous lidocaine gastroscopy bucking
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