Sedation
Conditions
Keywords
intravenous lidocaine gastroscopy bucking
Brief summary
Intravenous infusion of lidocaine significantly reduces incidence of bucking when perfomed gastroscopy.
Detailed description
This study divide patients into two groups, the patients in lidocaine group will be given lidocaine; the control group will be given placebo .the primary endopiont was to investigate whether intravenous lidocaine can reduce incidence of bucking and movement in sedation of gastroscopy.
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 80 Years
Healthy volunteers
Yes
Inclusion criteria
patients aged \>18 years who were scheduled for ERCP at Qilu hospital.
Exclusion criteria
patients with ASA (American Society of Anesthesiologists) Class 4 or 5, pre-existing hypoxemia (SpO2 \<90%), hypotension (systolic blood pressure \<90 mm Hg), bradycardia (HR\<50 beats/min), uncontrolled hypertension (SBP \>170 mm Hg, diastolic blood pressure\>100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to lidocaine, atrioventricular block, epilepsy, and inability to give informed consen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of bucking during the procedure | half a year | the difference between incidence of bucking of the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of infusion pain when adminstrated propofol | half a year | the infusion pain devied into no pain, mild pian, and severe pain |
| 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 |
| 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 |
| propofol consumption difference between the two groups | half a year | the total propofol dosage consumption between the two groups |
| patient satisfaction assessed by the patient | half a year | the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure |
| anesthetist satisfaction | half a year | the anesthetist satisfacition score were assessed on a 0-10VAS 30mins after the procedure |
| pain socre after the gastroscopy | 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
Backup Contactyanqing li
Outcome results
None listed