Intravenous Infusion of Lidocaine in Gastroscopy
- Registration Number
- NCT04439773
- Lead Sponsor
- Shandong University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
patients aged >18 years who were scheduled for ERCP at Qilu hospital.
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
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 lidocaine group Lidocaine the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h
- Primary Outcome Measures
Name Time Method the incidence of bucking during the procedure half a year the difference between incidence of bucking of the two groups
- Secondary Outcome Measures
Name Time Method propofol consumption difference between the two groups half a year the total propofol dosage consumption between the two groups
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
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
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
Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China