Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

NCT05274984 | Unknown Phase 1 DMC

• 1 other identifier: LIP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Safety assessed by the rate of hypoxia during the procedure

  During ERCP procedure

• Safety assessed by the rate of involuntary movement during the procedure

  During ERCP procedure

• Lidocaine

  During ERCP procedure

• Endoscopist satisfaction between 2 groups

  After ERCP procedure

Study Arms (2)

Group Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Group Lidocaine

ACTIVE COMPARATOR

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.

Group Placebo

Lidocaine DRUG

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

Group Lidocaine

Eligibility Criteria

• Age: 65 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years old
• physical status ASA I, II, III,
• ERCP scheduled

You may not qualify if:

• ASA IV or higher
• severe renal, cardiac or liver failure,
• allergy to lidocaine,
• patients weighing less than 40 kg,
• inability to give informed consent

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"

Cluj-Napoca, Cluj, 400162, Romania

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Daniela Ionescu, MD PhD

  UMF Iuliu Hatieganu Cluj-Napoca

  STUDY CHAIR

Central Study Contacts

Caius Breazu, MD PHD

CONTACT

0040743010012; csbreazu@yahoo.com

Alex Alexandru, MD

CONTACT

alexandru_reziati@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients, endoscopist, anesthetist, and data collection observers were all blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor MD PhD

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: February 17, 2022
• First Posted: March 11, 2022
• Study Start: January 3, 2022
• Primary Completion: March 3, 2022
• Study Completion: April 3, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)