Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

Sedation Clinical Trial

Official title:

Lidocaine Continuous Infusion for ERCP Procedures: a Prospective, Randomized, Double-blinded, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274984
• Other study ID #: LIP
• Status: Recruiting
• Phase: Phase 1
• Start date: January 3, 2022
• Est. completion date: April 3, 2022

Study information

• Verified date: March 2022
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Caius Breazu, MD PHD
• Phone: 0040743010012
• Email: csbreazu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old.

Description:

The primary aim of this study was to evaluate the effect of continuous infusion of lidocaine on propofol consumption in older patients having ERCP sedation. Secondary outcomes were to evaluate patient adverse events, sedation quality and satisfaction of the patient and the endoscopist, postprocedural pain, and sedation-related time.For this the investigators randomised patients into 2 groups: Group Lidocaine received 1,5 mg/kg lidocaine 1% 10 min before procedure and then 2 mg/kg/h continuous infusion of lidocaine 1%, whereas the Group Control received an equal volume of saline solution, which could not be visually identified from lidocaine by the blinded anaesthesiologist. All patients received propofol bolus dose of 1mg/kg than 10-20 mg iv boluses during the procedure guided by capnograph monitoring and the patient's grimace, mobility, hemodynamic changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 65-85 years old

• physical status ASA I, II, III,

• ERCP scheduled

Exclusion Criteria:

• ASA IV or higher

• severe renal, cardiac or liver failure,

• allergy to lidocaine,

• patients weighing less than 40 kg,

• inability to give informed consent

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 1.5mg/kg lidocaine and then 2mg/kg/h

Locations

Country	Name	City	State
Romania	Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Propofol consumption between the 2 groups	To evaluate propofol consumption by recording total dose of propofol(mg) during ERCP procedure between the 2 groups.	During ERCP procedure
Secondary	Safety assessed by the rate of hypoxia during the procedure	Recording the number of hypoxia episodes, defined as peripheral oxygen saturation <94% for >30 seconds during ERCP procedure between the 2 groups.	During ERCP procedure
Secondary	Safety assessed by the rate of involuntary movement during the procedure	Number of involuntary movements, defined as unconscious movements requiring restraint of patients during ERCP procedure between the 2 groups	During ERCP procedure
Secondary	Lidocaine	Asses the total dose of lidocaine (mg) used in GROUP Lidocaine during ERCP procedure	During ERCP procedure
Secondary	Endoscopist satisfaction between 2 groups	The endoscopists satisfaction score to be assessed on a 1-4 VAS after the procedure ( 1-poor, 2-moderate, 3-good, 4-excellent)	After ERCP procedure