Intravenous Infusion of Lidocaine in Colonoscopy

Phase 4

• Conditions: Sedation
• Interventions: Drug: lidocaine; Drug: placebo

• Registration Number: NCT04439786
• Lead Sponsor: Shandong University

Brief Summary

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

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 Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-18
• Study First Posted: 2020-06-19
• Last Update Posted: 2020-06-19
• Study Start: 2020-07-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine group	lidocaine	the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h
control group	placebo	the control group will be given the same volume of saline as the experimental group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China