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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"
Cluj-Napoca, Cluj, Romania
RECRUITINGPropofol consumption between the 2 groups
To evaluate propofol consumption by recording total dose of propofol(mg) during ERCP procedure between the 2 groups.
Time frame: During ERCP procedure
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.
Time frame: During ERCP procedure
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
Time frame: During ERCP procedure
Lidocaine
Asses the total dose of lidocaine (mg) used in GROUP Lidocaine during ERCP procedure
Time frame: During ERCP procedure
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)
Time frame: After ERCP procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.