Intravenous Infusion of Lidocaine in Colonoscopy

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

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

Study Overview

• Status: Unknown
• Conditions: Sedation
• Intervention / Treatment: Drug: placebo; Drug: lidocaine

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: control group; the control group will be given the same volume of saline as the experimental group	Drug: placebo; the control group will be given the same volume of saline.; Other Names: saline
EXPERIMENTAL: lidocaine group; the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h	Drug: lidocaine; the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h; Other Names: Compound Lidocaine Hydrochloride Injiection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fatigue score after colonoscopy	fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later	half a year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain socre after colonoscopy	pain were measured on a 0-10VAS at arrival in the recovery room ,30min later	half a year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by the rate of hypotention during the procedure	Hypotension, defined as systolic blood pressure <90 mmHg	half a year
Safety assessed by the rate of breadycardia during the procedure	Bradycardia, defined as heart rate <50 beats/min	half a year
infusion pain when adminstrate propofol	infusion pain was divided into no pain, mide pain and severe pain	half a year
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
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
Safety assessed by the rate of involuntary movement	Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement	half a year
endoscopists satisfaction assessed by the performer	the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure	half a year
patient satisfaction assessed by the patient	the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure	half a year
anesthetist satisfaction assessed by the anesthestist	the anesthetist satisfacition score were assessed on a 0-10VAS after the procedure	half a year

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (ACTUAL): June 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: intravenous lidocaine coloscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2020SDU-QILU-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No