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出境医 / 临床实验 / Intravenous Infusion of Lidocaine in ERCP

Intravenous Infusion of Lidocaine in ERCP

Study Description
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.
Study Design
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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;
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019) 		propofol consumption difference between the two groups [ Time Frame: half a year ]
the total propofol dosage consumption between the two groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 ERCP
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 propofol dose for ERCP and improve patients' recovery after ERCP.
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  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: Lidocaine
    the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
    Other Name: Compound Lidocaine Hydrochloride Injiection
  • Drug: placebo
    the control group will be given the same volume of saline.
    Other Name: saline
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: Experimental: lidocaine group
    the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h
    Intervention: Drug: Lidocaine
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.

*   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 20, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2019
Estimated Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: jing liu +86-18560083755 liujing2013@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996577
Other Study ID Numbers  ICMJE 2019SDU-QILU-071
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 Not Provided
Responsible Party Yanqing Li, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: yanqing li Qilu Hospital of Shandong University
PRS Account Shandong University
Verification Date September 2019

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

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