Gastric Neoplasm
Conditions
Brief summary
The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection. The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.
Interventions
DRUGLidocaine 1%
Intravenous administration as bolus of lidocaine 1.5 mg/kg before sedation and infusion of lidocaine 2 mg/kg/hr during sedation. Sedation with fentanyl and propofol
DRUGNormal saline
Intravenous administration as bolus of normal saline 0.15 mL/kg before sedation and infusion of normal saline 0.2 mL/kg/hr during sedation. Sedation with fentanyl and propofol
Sponsors
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\. Endoscopic submucosal dissection for the treatments of early gastric neoplasm
Exclusion criteria
1. Allergy to lidocaine 2. Chronic pain 3. Chronic abuse of opioid or NSAID 4. Atrioventricular conductance block 5. Liver dysfunction 6. Renal dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fentanyl consumption during sedation | During sedation, an expected average of 40 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by numerical rating scale | 30 min, 6 hr, and 24 hr after procedure | 0 = no pain at all and 10 = worst pain imaginable (11-point numerical rating scale) |
| Incidence of nausea and vomiting | Up to 24 hours | Nausea requiring antiemetics and retching and/or vomiting |
Countries
South Korea
Outcome results
None listed