Intravenous Infusion of Lidocaine in Gastroscopy

Shandong University130 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

130

Conditions

Sedation

Interventions

placeboDRUG

the control group will be given the same volume of saline.

LidocaineDRUG

the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

the incidence of bucking during the procedure

the difference between incidence of bucking of the two groups

Time frame: half a year

Secondary Outcomes

propofol consumption difference between the two groups

the total propofol dosage consumption between the two groups

Time frame: half a year

the incidence of infusion pain when adminstrated propofol

the infusion pain devied into no pain, mild pian, and severe pain

Time frame: half a year

Safety assessed by the rate of hypoxia during the procedure

Hypoxia, defined as peripheral oxygen saturation \<90% for \>30 seconds

Time frame: half a year

Safety assessed by the rate of hypotention during the procedure

Hypotension, defined as systolic blood pressure \<90 mmHg

Time frame: half a year

Safety assessed by the rate of breadycardia during the procedure

Bradycardia, defined as heart rate \<50 beats/min

Time frame: half a year

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

Time frame: half a year

endoscopists satisfaction assessed by the performer

Central Contacts

jing Liu

CONTACT

+86-18560083755 liujingqilu@126.com

yanqing li

CONTACT

86-531-82169236 liyanqing@sdu.edu.cn

Data from ClinicalTrials.gov

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