Sedation
Conditions
Keywords
lidocaine propofol ercp
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.
Interventions
DRUGLidocaine
the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
DRUGplacebo
the control group will be given the same volume of saline.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Inpatients aged \>18 years who were scheduled for ERCP at Qilu hospital.
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| propofol consumption difference between the two groups | half a year | the total propofol dosage consumption between the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by the rate of hypotention during the procedure | half a year | Hypotension, defined as systolic blood pressure \<90 mmHg |
| 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 |
| 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 |
| 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 |
| endoscopists satisfaction assessed by the performer | half a year | the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure |
Countries
China
Contacts
Primary Contactjing liu
Outcome results
None listed