Intravenous Infusion of Lidocaine in ERCP
- Registration Number
- NCT03996577
- Lead Sponsor
- Shandong University
- Brief Summary
Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP.
- Detailed Description
This study divide patients into two groups, one will be given lidocaine; another group was given placebo . to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inpatients aged >18 years who were scheduled for ERCP at Qilu hospital.
- Patients with ASA class 4 or 5,
- Patients with pre-existing hypoxaemia (SpO2<90%),
- Patients with hypotension (SBP<90mmHg)
- Patients with bradycardia (HR<50 bpm)
- patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- patients with pregnancy or lactation
- Patients hemodynamically unstable
- Patients unable to give informed consent
- Patients with a history of drug allergies;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group placebo the control group will be given the same volume of saline as the experimental group Experimental: lidocaine group Lidocaine the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h
- Primary Outcome Measures
Name Time Method propofol consumption difference between the two groups half a year the total propofol dosage consumption between the two groups
- Secondary Outcome Measures
Name Time Method Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure half a year Hypoxia, defined as peripheral oxygen saturation \<90% for \>30 seconds
Safety assessed by the rate of hypotention during the procedure half a year Hypotension, defined as systolic blood pressure \<90 mmHg
endoscopists satisfaction assessed by the performer half a year the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure
patient satisfaction assessed by the patient half a year the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure
pain socre after the ERCP half a year pain were measured on a 0-10VAS at arrival in the recovery room ,30min later
fatigue score after the ERCP half a year fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later
Safety assessed by the rate of breadycardia during the procedure half a year Bradycardia, defined as heart rate \<50 beats/min
Safety assessed by the rate of required airway management during the procedure half a year Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia
Safety assessed by the rate of involuntary movement during the procedure half a year Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure
Trial Locations
- Locations (2)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China