Intravenous Infusion of Lidocaine in Colonoscopy

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04439786
• Other study ID #: 2020SDU-QILU-021
• 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, MD
• Phone: +86-18560083755
• Email: liujingqilu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

intravenous infusion of lidocaine significantly reduce fatigue and pain and improve the patients satisfaction after sedation for colonoscopy.

Description:

This study divide patients into two groups, lidocaine group one will be given lidocaine intravenously; control group will be given saline . the difference between patients fatigue and pain will be compared. and the propofol consumption, pain after infusion of propofol, patients, endoscopists and anaesthesist satifaction, the incidence of hypotenstion, hypoxia, and bradycardia will aslo be compared between the two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• 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:

Inclusion Criteria: patients aged >18 years who were scheduled for colonscopy 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
Other	infusion pain when adminstrate propofol	infusion pain was divided into no pain, mide pain and severe pain	half a year
Other	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 >10 seconds	half a year
Other	Safety assessed by the rate of hypotention during the procedure	Hypotension, defined as systolic blood pressure <90 mmHg	half a year
Other	Safety assessed by the rate of breadycardia during the procedure	Bradycardia, defined as heart rate <50 beats/min	half a year
Other	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
Other	Safety assessed by the rate of involuntary movement	Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement	half a year
Other	endoscopists satisfaction assessed by the performer	the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure	half a year
Other	patient satisfaction assessed by the patient	the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure	half a year
Other	anesthetist satisfaction assessed by the anesthestist	the anesthetist satisfacition score were assessed on a 0-10VAS after the procedure	half a year
Primary	fatigue score after colonoscopy	fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later	half a year
Secondary	pain socre after colonoscopy	pain were measured on a 0-10VAS at arrival in the recovery room ,30min later	half a year