Intravenous Infusion of Lidocaine in Gastroscopy

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: NCT04439773
• Other study ID #: 2020SDU-QILU-022
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: Shandong University
• Contact: jing Liu
• Phone: +86-18560083755
• Email: liujingqilu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of bucking during the procedure	the difference between incidence of bucking of the two groups	half a year
Secondary	propofol consumption difference between the two groups	the total propofol dosage consumption between the two groups	half a year
Secondary	the incidence of infusion pain when adminstrated propofol	the infusion pain devied into no pain, mild pian, and severe pain	half a year
Secondary	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	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	anesthetist satisfaction	the anesthetist satisfacition score were assessed on a 0-10VAS 30mins after the procedure	half a year
Secondary	pain socre after the gastroscopy	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