Intravenous Infusion of Lidocaine in Gastroscopy

NCT ID: NCT04439773

Last Updated: 2020-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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control group

the control group will be given the same volume of saline as the experimental group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

lidocaine group

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

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

Interventions

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placebo

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

Intervention Type DRUG

Lidocaine

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

Intervention Type DRUG

Other Intervention Names

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saline Compound Lidocaine Hydrochloride Injiection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shan dong China

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jing Liu

Role: CONTACT

+86-18560083755

yanqing li

Role: CONTACT

86-531-82169236

Facility Contacts

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jinan shandong

Role: primary

Yanqing li

Role: backup

86-531-82169236

Other Identifiers

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2020SDU-QILU-022

Identifier Type: -

Identifier Source: org_study_id

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