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Intravenous Infusion of Lidocaine in Gastroscopy

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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

Tracking Information
First Submitted Date  ICMJE June 18, 2020
First Posted Date  ICMJE June 19, 2020
Last Update Posted Date June 19, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
the incidence of bucking during the procedure [ Time Frame: half a year ]
the difference between incidence of bucking of the two groups
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • propofol consumption difference between the two groups [ Time Frame: half a year ]
    the total propofol dosage consumption between the two groups
  • 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
  • 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
  • Safety assessed by the rate of hypotention during the procedure [ Time Frame: half a year ]
    Hypotension, defined as systolic blood pressure <90 mmHg
  • Safety assessed by the rate of breadycardia during the procedure [ Time Frame: half a year ]
    Bradycardia, defined as heart rate <50 beats/min
  • 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
  • endoscopists satisfaction assessed by the performer [ Time Frame: half a year ]
    the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure
  • 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
  • anesthetist satisfaction [ Time Frame: half a year ]
    the anesthetist satisfacition score were assessed on a 0-10VAS 30mins after the procedure
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Infusion of Lidocaine in Gastroscopy
Official Title  ICMJE Efficacy of Intravenous Infusion of Lidocaine in Sedation for ERCP: a Randomised Placebo-controlled Study
Brief Summary Intravenous infusion of lidocaine significantly reduces incidence of bucking when perfomed gastroscopy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Sedation
Intervention  ICMJE
  • Drug: placebo
    the control group will be given the same volume of saline.
    Other Name: saline
  • Drug: Lidocaine
    the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
    Other Name: Compound Lidocaine Hydrochloride Injiection
Study Arms  ICMJE
  • Placebo Comparator: control group
    the control group will be given the same volume of saline as the experimental group
    Intervention: Drug: placebo
  • Experimental: lidocaine group
    the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h
    Intervention: Drug: Lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2020)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: jing Liu +86-18560083755 liujingqilu@126.com
Contact: yanqing li 86-531-82169236 liyanqing@sdu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04439773
Other Study ID Numbers  ICMJE 2020SDU-QILU-022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yanqing Li, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shan dong China Qilu Hospital of Shandong University
PRS Account Shandong University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP