Intravenous Infusion of Lidocaine in ERCP

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996577
• Other study ID #: 2019SDU-QILU-071
• Status: Recruiting
• Phase: Phase 4
• Start date: May 15, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: September 2019
• Source: Shandong University
• Contact: jing liu
• Phone: +86-18560083755
• Email: liujing2013[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Lidocaine
the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
• placebo
the control group will be given the same volume of saline.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	propofol consumption difference between the two groups	the total propofol dosage consumption between the two groups	half a year
Secondary	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
Secondary	Safety assessed by the rate of hypotention during the procedure	Hypotension, defined as systolic blood pressure <90 mmHg	half a year
Secondary	Safety assessed by the rate of breadycardia during the procedure	Bradycardia, defined as heart rate <50 beats/min	half a year
Secondary	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
Secondary	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
Secondary	endoscopists satisfaction assessed by the performer	the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure	half a year
Secondary	patient satisfaction assessed by the patient	the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure	half a year
Secondary	pain socre after the ERCP	pain were measured on a 0-10VAS at arrival in the recovery room ,30min later	half a year
Secondary	fatigue score after the ERCP	fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later	half a year