Intravenous Infusion of Lidocaine in Gastroscopy

NCT04439773 | Unknown Phase 4 DMC

• 1 other identifier: 2020SDU-QILU-022
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sedation

Keywords

intravenous lidocaine gastroscopy bucking

Outcome Measures

Primary Outcomes (1)

• the incidence of bucking during the procedure

  the difference between incidence of bucking of the two groups

  half a year

Secondary Outcomes (11)

• propofol consumption difference between the two groups

  half a year

• the incidence of infusion pain when adminstrated propofol

  half a year

• Safety assessed by the rate of hypoxia during the procedure

  half a year

• Safety assessed by the rate of hypotention during the procedure

  half a year

• Safety assessed by the rate of breadycardia during the procedure

  half a year

Study Arms (2)

control group

PLACEBO COMPARATOR

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

Drug: placebo

lidocaine group

EXPERIMENTAL

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

Drug: Lidocaine

Interventions

placebo DRUG

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

Also known as: saline

control group

Lidocaine DRUG

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

Also known as: Compound Lidocaine Hydrochloride Injiection

lidocaine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged \>18 years who were scheduled for ERCP at Qilu hospital.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Sodium Chloride; Lidocaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Shan dong China

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

jing Liu

CONTACT

+86-18560083755; liujingqilu@126.com

yanqing li

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 19, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

CN (1)