Sedation
Conditions
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.
Detailed 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.
Interventions
DRUGPlacebo
the control group will be given the same volume of saline.
DRUGLidocaine
the experimental group will be given 1.5mg/kg lidocaine and then 2mg/kg/h
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patients, endoscopist, anesthetist, and data collection observers were all blinded to the group allocation.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Propofol consumption between the 2 groups | During ERCP procedure | To evaluate propofol consumption by recording total dose of propofol(mg) during ERCP procedure between the 2 groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by the rate of hypoxia during the procedure | During ERCP procedure | Recording the number of hypoxia episodes, defined as peripheral oxygen saturation \<94% for \>30 seconds during ERCP procedure between the 2 groups. |
| Safety assessed by the rate of involuntary movement during the procedure | During ERCP procedure | Number of involuntary movements, defined as unconscious movements requiring restraint of patients during ERCP procedure between the 2 groups |
| Lidocaine | During ERCP procedure | Asses the total dose of lidocaine (mg) used in GROUP Lidocaine during ERCP procedure |
| Endoscopist satisfaction between 2 groups | After ERCP procedure | The endoscopists satisfaction score to be assessed on a 1-4 VAS after the procedure ( 1-poor, 2-moderate, 3-good, 4-excellent) |
Countries
Romania
Contacts
Primary ContactCaius Breazu, MD PHD
Backup ContactAlex Alexandru, MD
Outcome results
None listed