Gastric Neoplasm Clinical Trial
Official title:
Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm
Verified date | December 2015 |
Source | Severance Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fentanyl consumption during sedation | During sedation, an expected average of 40 minutes | Yes | |
Secondary | Pain intensity measured by numerical rating scale | 0 = no pain at all and 10 = worst pain imaginable (11-point numerical rating scale) | 30 min, 6 hr, and 24 hr after procedure | No |
Secondary | Incidence of nausea and vomiting | Nausea requiring antiemetics and retching and/or vomiting | Up to 24 hours | Yes |
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